Data / Medical devices / United States / Respironics Inc.
Respironics Inc.: FDA-registered device maker in Murrysville, PA, United States, 122 510(k) clearances
Respironics Inc. is registered with the FDA (registration 2518422) in Murrysville, PA, United States. It lists 43 device types. The FDA files 122 510(k) clearances under its listings, the newest dated September 25, 2026. 65 recall events name it as the recalling firm (30 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2518422
- Address
- 1001 Murry Ridge Lane, Murrysville, PA, United States, 15668
- Owner or operator
- Philips Medical Systems International BV (2518422)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 8, 1992
- Registered through
- 2026
- Brand names listed
- 12/24V Battery Cable w/terminals or adapter, 920 & 920M Handheld Pulse Oximeter, 920M Plus Pulse Oximeter, A30 Heated Humidifier, A40 Heated Humidifier, AF421 FFM, AF531 FFM, AF531 Oro-Nasal EE Leak 1 Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Calculator, Pulmonary Function Data | BZC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous, Minimal Ventilatory Support, Facility Use Ventilator | MNT | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Drain, Tee (Water Trap) | BYH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pillow, Cervical (For Mild Sleep Apnea) | MYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Ventilator, External Body, Negative Pressure, Adult (Cuirass) | BYT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 122.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K261262 | Altis Full Face Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 30, 2024 | K243394 | AF531 Oro-Nasal SE Face Mask | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 31, 2024 | K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | BZD | Substantially Equivalent | Philips Respironics | accessdata.fda.gov |
| August 24, 2021 | K210844 | DreamWear Silicone Pillows Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 12, 2021 | K210386 | Magneto Nasal Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 29, 2020 | K202142 | Sleepware G3 | OLZ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| September 25, 2020 | K201439 | Ventilator, Non-continuous (Respirator) | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 10, 2020 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 18, 2019 | K183226 | Care Orchestrator Essence | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181170 | Trilogy Evo Universal | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181166 | Trilogy Evo | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| June 5, 2018 | K180608 | Lunoa System | MYB | Substantially Equivalent | Nightbalance BV | accessdata.fda.gov |
| April 15, 2016 | K151120 | Simple T Pediatric Nasal Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| September 18, 2015 | K150639 | AF541 EE Full Face Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| September 18, 2015 | K150638 | AF541 SE Full Face Mask | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 10, 2015 | K140980 | TI NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| January 9, 2015 | K142554 | Revolution Full Face Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 14, 2014 | K140424 | RESPIRONICS REUSABLE HEATED TUBING | BZE | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 20, 2014 | K140268 | SIMPLE T YOUTH NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 20, 2013 | K132168 | BRONCHOSCOPY ELBOW | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 18, 2013 | K131982 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| May 21, 2013 | K130077 | REMSTAR SE | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 6, 2013 | K122847 | KANGAROO NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 31, 2012 | K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | SDT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121955 | COUGHASSIST T70 DEVICE | NHJ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 9, 2012 | K122769 | REMSTAR SE | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 5, 2012 | K121631 | SIMPLE T NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 17, 2012 | K120562 | PERFORMAX PEDIATRIC EE TOTAL FACE MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 10, 2012 | K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 1, 2012 | K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 16, 2011 | K113068 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 4, 2011 | K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 25, 2011 | K102454 | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM | CAF | Substantially Equivalent | Respironics Respiratory Drug Delivery (Uk) , Ltd. | accessdata.fda.gov |
| October 14, 2011 | K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 4, 2011 | K111378 | OXIMETRY INTERFACE KIT | MNS | Substantially Equivalent | Philips Respironics, Inc. | accessdata.fda.gov |
| August 9, 2011 | K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| June 6, 2011 | K110405 | TRUBLUE NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| June 1, 2011 | K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | BZE | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| April 5, 2011 | K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 24, 2011 | K103395 | PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 24, 2011 | K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| September 16, 2010 | K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| September 2, 2010 | K101130 | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100428 | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 29, 2010 | K100285 | LITETOUCH MASK | CAF | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| May 12, 2010 | K093905 | TRILOGY 202 VENTILATOR | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 12, 2010 | K092835 | COMFORTGEL NASAL MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 29, 2010 | K093416 | TRILOGY 200 VENTILATOR | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| January 22, 2010 | K092818 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 18, 2009 | K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK | CBK | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| October 30, 2009 | K090539 | BIPAP AUTOSV ADVANCED | MNS | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| August 3, 2009 | K091319 | REMSTAR AUTO A-FLEX | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| June 26, 2009 | K090484 | ALICE PDX | MNR | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| May 29, 2009 | K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| May 8, 2009 | K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| March 25, 2009 | K082558 | COMFORTLITE NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 13, 2009 | K083526 | TRILOGY 100 VENTILATOR | CBK | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 26, 2009 | K083874 | GALAXY | MNR | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 9, 2009 | K082660 | V60 VENTILATOR, MODEL V8000 | MNT | Substantially Equivalent | Respironics California, Inc. | accessdata.fda.gov |
| June 5, 2008 | K081285 | FINGER PULSE OXIMETER, MODEL 9560 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| April 25, 2008 | K073600 | COMFORTGEL FULL FACE MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| March 31, 2008 | K073706 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. | accessdata.fda.gov |
| February 16, 2007 | K062689 | SIDESTREAM PLUS | CAF | Substantially Equivalent | Respironics , Ltd. | accessdata.fda.gov |
| June 28, 2006 | K061261 | L4 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| June 22, 2006 | K060404 | AG-PLUS, MODEL 91210 | CAF | Substantially Equivalent | Medel S.P.A. | accessdata.fda.gov |
| December 13, 2005 | K053063 | PRO-FLOW MULTIPURPOSE CANNULA | CCK | Substantially Equivalent | Pro-Tech Services, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052573 | STARDUST II | MNR | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 9, 2005 | K052941 | I-NEB INSIGHT AAD SYSTEM | CAF | Substantially Equivalent | Profile Therapeutics Plc | accessdata.fda.gov |
| February 11, 2005 | K043006 | MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 13, 2004 | K042655 | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 | CAF | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| May 5, 2004 | K041010 | REMSTAR AUTO WITH C-FLEX CPAP SYSTEM | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| April 22, 2004 | K033534 | VITALSENSE | FLL | Substantially Equivalent | Mini-Mitter Co., Inc. | accessdata.fda.gov |
| March 18, 2004 | K040595 | ALICE 5 | OLZ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 6, 2004 | K033823 | RESPIRONICS CUSTOM II ORAL APPLIANCE | LRK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 13, 2003 | K032809 | HOSPITAL SPACER | CAF | Substantially Equivalent | Respironics Healthscan, Inc. | accessdata.fda.gov |
| October 17, 2003 | K030668 | MODEL 3100 WRISTOX PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| April 25, 2003 | K022294 | APNEACHECK | MNR | Substantially Equivalent | Im Systems | accessdata.fda.gov |
| January 3, 2003 | K023135 | IMAGE3 SE DISPOSABLE FULL FACE MASK | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| June 19, 2002 | K021861 | REMSTAR PRO WITH C-FLEX CPAP SYSTEM | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| April 22, 2002 | K013905 | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS | MNR | Substantially Equivalent | Pro-Tech Services, Inc. | accessdata.fda.gov |
| October 15, 2001 | K010997 | PAM-RL | GWQ | Substantially Equivalent | Individual Monitoring Systems, Inc. | accessdata.fda.gov |
| March 29, 2001 | K010263 | REMSTAR PLUS CPAP SYSTEM | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 11, 2000 | K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| September 8, 2000 | K002465 | SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 20, 2000 | K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| November 26, 1999 | K991105 | ECG ELECTRODE (VARIOUS) | DRX | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| November 10, 1999 | K992969 | RESPIRONICS TOTAL FACE MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 30, 1999 | K991725 | SIDESTREAM NEBULIZER | CAF | Substantially Equivalent | Inspired Medical Products , Ltd. | accessdata.fda.gov |
| March 23, 1999 | K983533 | ACTIWATCH | GWQ | Substantially Equivalent | Mini-Mitter Co., Inc. | accessdata.fda.gov |
| March 9, 1999 | K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | BYE | Substantially Equivalent | Caradyne, Ltd. | accessdata.fda.gov |
| November 3, 1998 | K982454 | BIPAP VISION VENTILATORY SUPPORT | MNT | Substantially Equivalent - Subject to Tracking Reg. | Respironics, Inc. | accessdata.fda.gov |
| July 13, 1998 | K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR | MNR | Substantially Equivalent | Pro-Tech Services, Inc. | accessdata.fda.gov |
| January 22, 1997 | K963380 | CO 2 SMO PLUS | BZC | Substantially Equivalent | Novametrix Medical Systems, Inc. | accessdata.fda.gov |
| December 5, 1996 | K962203 | WHISPER SWIVEL II EXHALATION PORT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 14, 1996 | K963250 | PRESSURE VALVE | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 25, 1996 | K962924 | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | BZH | Substantially Equivalent | Healthscan Products, Inc. | accessdata.fda.gov |
| October 17, 1996 | K962822 | OPTICHAMBER | CAF | Substantially Equivalent | Healthscan Products, Inc. | accessdata.fda.gov |
| September 17, 1996 | K960851 | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR | BZQ | Substantially Equivalent - Subject to Tracking Reg. | Pro-Tech Services, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 2, 2026 | 98540 | Class I | Ongoing | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | accessdata.fda.gov |
| March 2, 2026 | 98537 | Class I | Ongoing | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | accessdata.fda.gov |
| October 7, 2025 | 97736 | Class II | Ongoing | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600 | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperatu | accessdata.fda.gov |
| June 30, 2025 | 97191 | Class I | Ongoing | DreamStation Auto CPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | accessdata.fda.gov |
| May 9, 2025 | 96948 | Class I | Ongoing | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg. | This device does not indicate for use in patients with respiratory failure. | accessdata.fda.gov |
| October 7, 2024 | 95486 | Class I | Ongoing | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | accessdata.fda.gov |
| July 16, 2024 | 95078 | Class I | Ongoing | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV3 | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | accessdata.fda.gov |
| April 1, 2024 | 94487 | Class I | Ongoing | OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. | accessdata.fda.gov |
| March 26, 2024 | 94475 | Class I | Ongoing | BiPAP V30 Auto Ventilator, Part Number 1111178 | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients. | accessdata.fda.gov |
| March 19, 2024 | 94263 | Class I | Ongoing | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | accessdata.fda.gov |
| November 27, 2023 | 93609 | Class II | Ongoing | Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X1 | The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of exces | accessdata.fda.gov |
| August 25, 2023 | 93015 | Class I | Ongoing | Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. | accessdata.fda.gov |
| May 25, 2023 | 92515 | Class II | Ongoing | Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use | There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". | accessdata.fda.gov |
| May 1, 2023 | 92048 | Class I | Ongoing | Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider. | accessdata.fda.gov |
| March 1, 2023 | 91832 | Class I | Ongoing | Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, P | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. | accessdata.fda.gov |
| February 10, 2023 | 91837 | Class I | Ongoing | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep A | A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient. | accessdata.fda.gov |
| December 7, 2022 | 91293 | Class I | Ongoing | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 10 | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. | accessdata.fda.gov |
| September 6, 2022 | 90705 | Class I | Ongoing | Philips Respironics Amara View Minimal Contact Full-Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | accessdata.fda.gov |
| August 26, 2022 | 90695 | Class I | Ongoing | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | accessdata.fda.gov |
| February 28, 2022 | 89767 | Class I | Ongoing | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709) | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. | accessdata.fda.gov |
| January 24, 2022 | 89490 | Class I | Ongoing | Philips Respironics V60 Ventilator Part Number 1053617 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdow | accessdata.fda.gov |
| December 22, 2021 | 89276 | Class I | Ongoing | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventil | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inha | accessdata.fda.gov |
| July 26, 2021 | 88333 | Class II | Ongoing | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, L | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage). | accessdata.fda.gov |
| June 18, 2021 | 88127 | Class I | Ongoing | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously brea | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm, the system will reduce pr | accessdata.fda.gov |
| June 14, 2021 | 88071 | Class I | Ongoing | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | accessdata.fda.gov |
| June 14, 2021 | 88058 | Class I | Ongoing | Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | accessdata.fda.gov |
| April 6, 2021 | 87753 | Class II | Terminated | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178 | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asp | accessdata.fda.gov |
| January 6, 2021 | 87314 | Class II | Ongoing | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfac | Due to unqualified "design verification" batteries being shipped to customers. | accessdata.fda.gov |
| November 2, 2020 | 86697 | Class II | Ongoing | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessori | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. | accessdata.fda.gov |
| October 30, 2020 | 86646 | Class II | Terminated | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessori | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | accessdata.fda.gov |
| March 5, 2020 | 85113 | Class II | Ongoing | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Fail | accessdata.fda.gov |
| November 19, 2019 | 84406 | Class I | Terminated | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2 | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439. | accessdata.fda.gov |
| September 11, 2019 | 83980 | Class II | Ongoing | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to funct | accessdata.fda.gov |
| June 12, 2018 | 89584 | Class I | Ongoing | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used fo | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices. | accessdata.fda.gov |
| April 24, 2017 | 77084 | Class I | Terminated | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, | Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event. | accessdata.fda.gov |
| February 1, 2017 | 76377 | Class II | Terminated | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator | The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease. | accessdata.fda.gov |
| October 29, 2014 | 69728 | Class II | Terminated | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medica | If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted. | accessdata.fda.gov |
| September 17, 2014 | 69313 | Class I | Terminated | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified m | A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia. | accessdata.fda.gov |
| February 11, 2014 | 67550 | Class I | Terminated | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through | Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. | accessdata.fda.gov |
| June 4, 2013 | 65376 | Class I | Terminated | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 105 | Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. | accessdata.fda.gov |
| July 31, 2012 | 62848 | Class I | Terminated | V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals | Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the | accessdata.fda.gov |
| April 27, 2012 | 62393 | Class I | Terminated | Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is int | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. | accessdata.fda.gov |
| October 11, 2011 | 60099 | Not yet classified | Terminated | Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilat | Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy. | accessdata.fda.gov |
| July 2, 2010 | 56147 | Not yet classified | Terminated | Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA. | Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage. | accessdata.fda.gov |
| June 10, 2010 | 55939 | Not yet classified | Terminated | Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mecha | It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event. | accessdata.fda.gov |
| October 26, 2009 | 53676 | Not yet classified | Terminated | RESPIRONICS V60 VENTILATOR | The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can re | accessdata.fda.gov |
| April 23, 2009 | 51886 | Not yet classified | Terminated | SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for per | Audible alarm failure. | accessdata.fda.gov |
| April 22, 2009 | 52439 | Not yet classified | Terminated | Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456. | The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in thi | accessdata.fda.gov |
| September 22, 2008 | 52016 | Not yet classified | Terminated | Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, r | Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in | accessdata.fda.gov |
| July 8, 2008 | 48980 | Not yet classified | Terminated | PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Life suppo | Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure. | accessdata.fda.gov |
| January 25, 2008 | 46818 | Not yet classified | Terminated | Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. | This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator. | accessdata.fda.gov |
| October 29, 2007 | 48997 | Class II | Terminated | Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 | The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable. | accessdata.fda.gov |
| October 15, 2007 | 45545 | Not yet classified | Terminated | BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | accessdata.fda.gov |
| October 25, 2006 | 36649 | Not yet classified | Terminated | REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. | AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device | accessdata.fda.gov |
| August 8, 2006 | 36161 | Not yet classified | Terminated | Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246 | This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases in which a fan also failed, have sho | accessdata.fda.gov |
| March 20, 2006 | 35056 | Not yet classified | Terminated | Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the pati | Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs. | accessdata.fda.gov |
| December 27, 2005 | 34390 | Not yet classified | Terminated | NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous) | Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier. | accessdata.fda.gov |
| November 18, 2005 | 34129 | Not yet classified | Terminated | The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an intern | During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient. | accessdata.fda.gov |
| September 19, 2005 | 35608 | Not yet classified | Terminated | NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 | Gas input pressures over 62 psi may cause CPAP pressure oscillation | accessdata.fda.gov |
| June 4, 2004 | 29333 | Not yet classified | Terminated | Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter. | Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected. | accessdata.fda.gov |
| September 29, 2003 | 27436 | Not yet classified | Terminated | ComfortGel Nasal Mask size small | product does not contain built in exhalation port | accessdata.fda.gov |
| July 14, 2003 | 28263 | Not yet classified | Terminated | Esprit Ventilator. | Valves may stick in the closed position due to manufacturing error. | accessdata.fda.gov |
| February 20, 2002 | 29385 | Not yet classified | Terminated | Esprit Ventilator | Flow sensors would exhibit drift. | accessdata.fda.gov |
| June 8, 2001 | 26432 | Not yet classified | Terminated | ESPRIT VENTILATOR, Model V1000 | Material hardness on original design check valve may cause premature failure. | accessdata.fda.gov |
| June 1, 2001 | 28803 | Not yet classified | Terminated | Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics | Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue. | accessdata.fda.gov |
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Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.