Data / Medical devices / United States / Spacelabs Healthcare Inc.
Spacelabs Healthcare Inc.: FDA-registered device maker in Snoqualmie, WA, United States, 35 510(k) clearances
Spacelabs Healthcare Inc. is registered with the FDA (registration 3010157426) in Snoqualmie, WA, United States. It lists 34 device types. The FDA files 35 510(k) clearances under its listings, the newest dated November 7, 2022. 70 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010157426
- Address
- 35301 SE Center St, Snoqualmie, WA, United States, 98065
- Owner or operator
- SPACELABS HEALTHCARE, INC. (2022906)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 13, 1994
- Registered through
- 2026
- Brand names listed
- 21.5 inch display, P/N 011-0241-02, 21.5 inch display, P/N 011-0262-00, 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169, 700 series ventilators, 900 Series Ventilator, 90516, 98900 Eclipse Mini and Assoc. Supplies & Accessories, Ambulatory Blood Pressure Cuffs and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2022 | K212317 | Eclipse MINI Model 98900 | MWJ | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| October 30, 2020 | K193421 | Smart Alarm Interface | MSX | Substantially Equivalent | Boxview, LLC | accessdata.fda.gov |
| September 11, 2019 | K183370 | PeraMobile and PeraWatch | MWI | Substantially Equivalent | Perahealth, Inc. | accessdata.fda.gov |
| May 1, 2018 | K172959 | PeraServer and PeraTrend | MWI | Substantially Equivalent | Perahealth, Inc. | accessdata.fda.gov |
| November 5, 2015 | K150329 | elance Vital Signs Monitor, Central Monitor Software | MHX | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| October 27, 2015 | K152801 | ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT | DXQ | Substantially Equivalent | Statcorp Medical | accessdata.fda.gov |
| September 26, 2014 | K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | DXN | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| September 9, 2014 | K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER | MHX | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| June 4, 2013 | K122365 | ULTRACHECK CURVE BLOOD PRESSURE CUFFS | OED | Substantially Equivalent | Statcorp Medical | accessdata.fda.gov |
| April 22, 2013 | K122146 | XHIBIT CENTRAL STATION, MODEL 96102 | MHX | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| March 21, 2013 | K130112 | CAPNO MODULE, 92517 | CCK | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| July 13, 2012 | K121017 | CAPNOGRAPHY PAD (92516) | CCK | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| June 6, 2012 | K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) | MHX | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| March 29, 2012 | K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| November 2, 2011 | K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| October 5, 2011 | K112173 | SPEACELABS MULTIGAS MODULE | CBR | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| April 19, 2011 | K110779 | SPACELABS SMART DISCLOSURE SYSTEM | DQK | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| March 3, 2011 | K103142 | SPACELABS MULTI-PARAMETER MODULE | DSI | Substantially Equivalent | Spacelabs Healthcare, Inc. | accessdata.fda.gov |
| December 7, 2010 | K102422 | SPACELABS MEDICAL PATIENT MONITORS | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| August 1, 2008 | K082045 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| December 20, 2007 | K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | OED | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| March 15, 2007 | K063490 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 | DQK | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| September 19, 2006 | K062278 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 | MSX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| June 23, 2006 | K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | OLW | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| April 19, 2006 | K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | CBR | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| December 4, 2003 | K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR | MHX | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 3, 1999 | K983996 | SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| February 6, 1996 | K954282 | ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG | DXQ | Substantially Equivalent | Statcorp, Inc. | accessdata.fda.gov |
| October 27, 1994 | K925510 | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING | DSI | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| October 6, 1994 | K941165 | COMET CAPNOGRAPH MODULE | CCK | Substantially Equivalent | Spacelabs, Inc. | accessdata.fda.gov |
| March 2, 1994 | K932842 | SPACELABS MEDICAL MODEL 90481 EEG MODULE | GWQ | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| February 22, 1994 | K940214 | STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Statcorp, Inc. | accessdata.fda.gov |
| October 19, 1990 | K903702 | MODEL 90421 FLEXPORT INTERFACE | DQA | Substantially Equivalent | Spacelabs, Inc. | accessdata.fda.gov |
| September 13, 1989 | K893867 | CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE | DQA | Substantially Equivalent | Spacelabs, Inc. | accessdata.fda.gov |
| October 18, 1984 | K842616 | SPACELABS ALPHA PC PATIENT COMPUTER | DSI | Substantially Equivalent | Spacelabs, 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 |
|---|---|---|---|---|---|---|
| June 4, 2026 | 99260 | Class II | Ongoing | Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remot | Due to off-the-shelf display port component that has audio/video failures | accessdata.fda.gov |
| March 26, 2026 | 98722 | Class II | Ongoing | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient mon | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | accessdata.fda.gov |
| February 27, 2026 | 98374 | Class II | Ongoing | Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed | accessdata.fda.gov |
| September 5, 2025 | 97616 | Class II | Ongoing | Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. | accessdata.fda.gov |
| November 25, 2024 | 95927 | Class II | Ongoing | Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data. | Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delaye | accessdata.fda.gov |
| November 25, 2024 | 95910 | Class II | Ongoing | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. | Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be del | accessdata.fda.gov |
| April 12, 2023 | 91851 | Class II | Ongoing | Ultraview SL (UVSL) Command Module, Model 91496 | Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event. | accessdata.fda.gov |
| May 31, 2022 | 90529 | Class II | Ongoing | Xhibit Telemetry Receiver, Model: 96280 | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aw | accessdata.fda.gov |
| August 30, 2019 | 85325 | Class II | Terminated | Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient | The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. | accessdata.fda.gov |
| January 28, 2019 | 83220 | Class II | Terminated | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. | Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. | accessdata.fda.gov |
| January 17, 2018 | 78989 | Class II | Terminated | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. | accessdata.fda.gov |
| April 14, 2017 | 77019 | Class II | Terminated | Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part n | Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient. | accessdata.fda.gov |
| October 18, 2016 | 75477 | Class II | Terminated | Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors an | The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally. | accessdata.fda.gov |
| August 25, 2016 | 75078 | Class II | Terminated | Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. | The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital. | accessdata.fda.gov |
| July 1, 2016 | 74549 | Class II | Terminated | 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. | The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data. | accessdata.fda.gov |
| March 28, 2016 | 73634 | Class II | Terminated | The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor. | Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored. | accessdata.fda.gov |
| February 26, 2016 | 73393 | Class II | Terminated | Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry | The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error. | accessdata.fda.gov |
| September 3, 2015 | 72211 | Class II | Terminated | Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiog | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally. | accessdata.fda.gov |
| May 8, 2015 | 71233 | Class II | Terminated | Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other | The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013). | accessdata.fda.gov |
| April 21, 2015 | 71118 | Class II | Terminated | Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and proc | Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets. | accessdata.fda.gov |
| April 17, 2015 | 71074 | Class II | Terminated | Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monito | Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values. | accessdata.fda.gov |
| January 28, 2015 | 70453 | Class II | Terminated | Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDL | Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset. | accessdata.fda.gov |
| August 26, 2014 | 69223 | Class II | Terminated | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011). | accessdata.fda.gov |
| July 2, 2014 | 69125 | Class II | Terminated | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all rec | accessdata.fda.gov |
| June 18, 2014 | 68611 | Class II | Terminated | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agen | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. | accessdata.fda.gov |
| June 6, 2014 | 68491 | Class II | Terminated | Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces | Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of | accessdata.fda.gov |
| May 9, 2014 | 68374 | Class II | Terminated | Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 | Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor. | accessdata.fda.gov |
| May 8, 2014 | 68357 | Class II | Terminated | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinic | A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. | accessdata.fda.gov |
| February 14, 2014 | 67638 | Class II | Terminated | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access. | accessdata.fda.gov |
| December 19, 2013 | 67243 | Class II | Terminated | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. | The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. | accessdata.fda.gov |
| October 17, 2013 | 66727 | Class II | Terminated | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. | accessdata.fda.gov |
| October 17, 2013 | 66726 | Class II | Terminated | Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. | Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors. | accessdata.fda.gov |
| December 5, 2012 | 63931 | Class II | Terminated | Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead r | Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810. | accessdata.fda.gov |
| October 19, 2012 | 63504 | Class II | Terminated | qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 reso | Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short. | accessdata.fda.gov |
| October 5, 2012 | 63506 | Class II | Terminated | The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inch | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. | accessdata.fda.gov |
| August 27, 2012 | 63007 | Class II | Terminated | Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) | There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. | accessdata.fda.gov |
| June 12, 2012 | 62437 | Class II | Terminated | Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert th | There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor. | accessdata.fda.gov |
| May 22, 2012 | 61919 | Not yet classified | Terminated | Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or ot | The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involuntarily shut down. | accessdata.fda.gov |
| May 11, 2012 | 61913 | Class II | Terminated | The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory | The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker. | accessdata.fda.gov |
| November 3, 2011 | 60593 | Not yet classified | Terminated | Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neo | NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail. | accessdata.fda.gov |
| July 13, 2011 | 60764 | Not yet classified | Terminated | Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parame | One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error. | accessdata.fda.gov |
| July 8, 2011 | 59456 | Not yet classified | Terminated | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (option D), which includ | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. | accessdata.fda.gov |
| July 6, 2011 | 59441 | Not yet classified | Terminated | Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection. | Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient. | accessdata.fda.gov |
| June 8, 2011 | 59136 | Not yet classified | Terminated | Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxid | Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data. | accessdata.fda.gov |
| May 24, 2011 | 59004 | Not yet classified | Terminated | Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO | A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed. | accessdata.fda.gov |
| May 12, 2011 | 58811 | Not yet classified | Terminated | The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory | Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings. | accessdata.fda.gov |
| March 24, 2011 | 58402 | Not yet classified | Terminated | Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers begi | The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings. | accessdata.fda.gov |
| September 23, 2010 | 56839 | Not yet classified | Terminated | Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healt | The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU. | accessdata.fda.gov |
| September 17, 2010 | 56806 | Not yet classified | Terminated | Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated f | Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem. | accessdata.fda.gov |
| June 24, 2010 | 56057 | Not yet classified | Terminated | BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room. | Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop. | accessdata.fda.gov |
| April 14, 2010 | 55319 | Not yet classified | Terminated | The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen displa | There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries. | accessdata.fda.gov |
| November 6, 2009 | 53779 | Not yet classified | Terminated | Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based | Potential for monitor to shut down and not being able to power on again. | accessdata.fda.gov |
| October 23, 2009 | 53863 | Not yet classified | Terminated | The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems | The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment. | accessdata.fda.gov |
| July 23, 2009 | 53124 | Not yet classified | Terminated | Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offere | The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock. | accessdata.fda.gov |
| June 25, 2009 | 57348 | Not yet classified | Terminated | Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by | Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems. | accessdata.fda.gov |
| March 20, 2009 | 57370 | Not yet classified | Terminated | Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256. | The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank. | accessdata.fda.gov |
| October 17, 2008 | 50226 | Not yet classified | Terminated | Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option | Potential for device to print out the wrong waveform data for the time indicated in the printout or display. | accessdata.fda.gov |
| July 22, 2008 | 48759 | Not yet classified | Terminated | Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populat | Potential for module to fail to obtain a NIBP reading on hypertension patients. | accessdata.fda.gov |
| July 18, 2008 | 48985 | Not yet classified | Terminated | Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, includ | Telemetry Modules are failing to alarm for low heart rate and asystole. | accessdata.fda.gov |
| July 17, 2008 | 48973 | Not yet classified | Terminated | Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, inc | During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes. | accessdata.fda.gov |
| July 2, 2008 | 48744 | Not yet classified | Terminated | Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical | Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed. | accessdata.fda.gov |
| October 8, 2007 | 44965 | Not yet classified | Terminated | Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027 | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. | accessdata.fda.gov |
| January 3, 2007 | 37077 | Not yet classified | Terminated | Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor. | Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment. | accessdata.fda.gov |
| May 5, 2006 | 35391 | Not yet classified | Terminated | Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver. | Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes. | accessdata.fda.gov |
| October 13, 2005 | 33769 | Not yet classified | Terminated | BirthNet OB Data Management System 91861 | Potential for incorrect weight to be displayed. | accessdata.fda.gov |
| September 16, 2005 | 33458 | Not yet classified | Terminated | Tru-Link DIN unshielded ECG cable, 5-lead | ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect. | accessdata.fda.gov |
| July 20, 2005 | 32815 | Not yet classified | Terminated | Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulator | The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes. | accessdata.fda.gov |
| January 7, 2005 | 30797 | Not yet classified | Terminated | Ultraview Universal Clinical Workstation System Model 90385. | Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients. | accessdata.fda.gov |
| May 7, 2004 | 29038 | Not yet classified | Terminated | Ultraview Universal Clinical Workstation Model 90385. | Potential for telemetry channels to drop off display. | accessdata.fda.gov |
| October 29, 2003 | 27598 | Not yet classified | Terminated | Spacelabs flat panel monitor, Model 91415-A | Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Ventilator, Continuous, Facility Use
- All makers of Detector And Alarm, Arrhythmia
- All makers of Computer, Diagnostic, Pre-Programmed, Single-Function
- All makers of Oximeter
Updated August 7, 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.