Data / Medical devices / United States / Physio-Control, Inc.
Physio-Control, Inc.: FDA-registered device maker in Redmond, WA, United States, 9 510(k) clearances and 4 PMA approvals
Physio-Control, Inc. is registered with the FDA (registration 3015876) in Redmond, WA, United States. It lists 14 device types. The FDA files 9 510(k) clearances and 4 PMA approvals under its listings, the newest dated October 14, 2025. 71 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015876
- Address
- 11811 Willows RD., N.E., Redmond, WA, United States, 98052
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 13, 2017
- Registered through
- 2027
- Brand names listed
- LIFEPAK 1000, LIFEPAK 15, LIFEPAK 15 AC Power Adapter, LIFEPAK 20, LIFEPAK 20E, LIFEPAK 35, LIFEPAK CR Plus, LIFEPAK CR2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator | MPD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Compressor, Cardiac, External | DRM | 2 | Complaint file establishment | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prep Kit | PXD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Recorder, Paper Chart | DSF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2025 | K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | MPD | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
| May 7, 2024 | K240377 | LIFEPAK® ECG Cables | DSA | Substantially Equivalent | Stryker Physio-Control | accessdata.fda.gov |
| April 30, 2024 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | DSA | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
| April 19, 2024 | K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | MPD | Substantially Equivalent | Stryker Physio-Control | accessdata.fda.gov |
| June 3, 2019 | K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | LDD | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
| February 8, 2018 | K173553 | LUCAS 3 Chest Compression System | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
| November 9, 2016 | K161768 | LUCAS 3 Chest Compression System | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
| December 19, 2014 | K142430 | LIFEPAK 15 monitor/defibrillator | MKJ | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
| June 17, 2009 | K090422 | LUCAS 2 | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 7, 2020 | P190007 | Cardinal Health Multifunctional Defibrillation Electrode | MKJ | 0 | August 7, 2020 | accessdata.fda.gov |
| December 21, 2018 | P170018 | LIFEPAK® CR2 Defibrillator | MKJ | 25 | July 30, 2026 | accessdata.fda.gov |
| July 2, 2018 | P160026 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE | MKJ | 71 | September 24, 2026 | accessdata.fda.gov |
| December 21, 2017 | P160012 | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger | MKJ | 6 | April 18, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | 98418 | Class II | Ongoing | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-0 | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy. | accessdata.fda.gov |
| January 21, 2026 | 98257 | Class II | Ongoing | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrill | Due to pediatric defibrillator electrode delamination | accessdata.fda.gov |
| July 22, 2025 | 96949 | Class II | Ongoing | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 | Due to required inspections not being performed on products/units that have gone through servicing. | accessdata.fda.gov |
| February 3, 2025 | 96095 | Class II | Ongoing | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | accessdata.fda.gov |
| January 21, 2025 | 96048 | Class II | Ongoing | LIFEPAK 35 ECG cable REF 11111-000041 | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | accessdata.fda.gov |
| January 21, 2025 | 95766 | Class II | Ongoing | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sensor REF 11996-000519 Masimo LNCS-II rainbo | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. | accessdata.fda.gov |
| August 30, 2024 | 95373 | Class II | Ongoing | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 | Due to an out of tolerance tool being used on monitor/defibrillator systems. | accessdata.fda.gov |
| August 9, 2024 | 95242 | Class II | Ongoing | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fi | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles. | accessdata.fda.gov |
| November 6, 2023 | 93234 | Class II | Ongoing | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. | accessdata.fda.gov |
| September 29, 2023 | 93233 | Class II | Ongoing | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | accessdata.fda.gov |
| January 13, 2022 | 89536 | Class III | Terminated | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | accessdata.fda.gov |
| January 14, 2021 | 87217 | Class II | Ongoing | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evalu | Due to complaints received regarding missing lid magnets which may result in premature battery depletion. | accessdata.fda.gov |
| April 24, 2020 | 85173 | Class II | Terminated | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to | Packaging of infant child reduced energy electrodes was not properly sealed. | accessdata.fda.gov |
| March 20, 2020 | 85194 | Class II | Terminated | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisor | Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment | accessdata.fda.gov |
| December 20, 2019 | 84425 | Class II | Terminated | LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad. | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button. | accessdata.fda.gov |
| February 1, 2019 | 81939 | Class I | Terminated | LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patien | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions. | accessdata.fda.gov |
| December 4, 2017 | 78574 | Class I | Terminated | LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/m | Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a fa | accessdata.fda.gov |
| October 27, 2017 | 78303 | Class I | Terminated | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 B | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. | accessdata.fda.gov |
| January 16, 2017 | 76162 | Class II | Terminated | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. | accessdata.fda.gov |
| January 13, 2017 | 76252 | Class I | Terminated | The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. | accessdata.fda.gov |
| January 12, 2017 | 76160 | Class I | Terminated | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA). | accessdata.fda.gov |
| May 25, 2016 | 74198 | Class II | Terminated | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest. | LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential res | accessdata.fda.gov |
| January 27, 2016 | 73473 | Class II | Terminated | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defi | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting. | accessdata.fda.gov |
| May 9, 2014 | 67963 | Class II | Terminated | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A sof | accessdata.fda.gov |
| June 12, 2013 | 65565 | Class II | Terminated | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicate | The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable. | accessdata.fda.gov |
| February 8, 2013 | 64427 | Class II | Terminated | The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators. | LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue. | accessdata.fda.gov |
| June 6, 2011 | 59109 | Not yet classified | Terminated | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicate | The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly. | accessdata.fda.gov |
| May 11, 2011 | 58822 | Not yet classified | Terminated | 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that | The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications. | accessdata.fda.gov |
| October 1, 2010 | 57563 | Not yet classified | Terminated | The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physici | L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibri | accessdata.fda.gov |
| May 27, 2010 | 55875 | Not yet classified | Terminated | The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac ca | A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted. | accessdata.fda.gov |
| May 27, 2010 | 55853 | Not yet classified | Terminated | LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000. | A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate. | accessdata.fda.gov |
| March 11, 2010 | 75743 | Class II | Terminated | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX | Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective actio | accessdata.fda.gov |
| March 4, 2010 | 54894 | Not yet classified | Terminated | Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system | Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off. | accessdata.fda.gov |
| August 12, 2009 | 53087 | Not yet classified | Terminated | Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual o | Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances | accessdata.fda.gov |
| July 31, 2009 | 53035 | Not yet classified | Terminated | Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 m | The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy. | accessdata.fda.gov |
| March 31, 2009 | 54005 | Not yet classified | Terminated | Biphasic LIFEPAK 12 defibrillator / monitor. | Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contri | accessdata.fda.gov |
| February 16, 2009 | 51173 | Not yet classified | Terminated | Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. | Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling. | accessdata.fda.gov |
| December 30, 2008 | 60202 | Not yet classified | Terminated | The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487 | When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. | accessdata.fda.gov |
| November 17, 2008 | 50214 | Not yet classified | Terminated | External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. | Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments. | accessdata.fda.gov |
| August 28, 2008 | 49396 | Not yet classified | Terminated | LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of s | This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic d | accessdata.fda.gov |
| July 24, 2008 | 49056 | Not yet classified | Terminated | LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Will | The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy. | accessdata.fda.gov |
| June 18, 2008 | 48748 | Not yet classified | Terminated | Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias. | Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate. | accessdata.fda.gov |
| May 13, 2008 | 48139 | Not yet classified | Terminated | Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically. | A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation t | accessdata.fda.gov |
| May 8, 2008 | 48140 | Not yet classified | Terminated | Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic sett | The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. | accessdata.fda.gov |
| April 16, 2008 | 47822 | Not yet classified | Terminated | Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. | The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no w | accessdata.fda.gov |
| February 27, 2008 | 46921 | Not yet classified | Terminated | FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/ | Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries. | accessdata.fda.gov |
| February 27, 2008 | 46918 | Not yet classified | Terminated | LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. | Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed. | accessdata.fda.gov |
| January 29, 2008 | 46749 | Not yet classified | Terminated | Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P. | Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented. | accessdata.fda.gov |
| January 8, 2008 | 46351 | Not yet classified | Terminated | Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052 | Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA). | accessdata.fda.gov |
| June 13, 2007 | 38232 | Not yet classified | Terminated | biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX. (XXXX indicates various non-contiguous numbers) | Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J. | accessdata.fda.gov |
| April 27, 2007 | 37864 | Not yet classified | Terminated | LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinic | White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment. | accessdata.fda.gov |
| March 30, 2007 | 37692 | Not yet classified | Terminated | LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinic | Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power. | accessdata.fda.gov |
| March 2, 2007 | 37490 | Not yet classified | Terminated | LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator | LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement. | accessdata.fda.gov |
| October 5, 2006 | 36484 | Not yet classified | Terminated | LIFEPAK CR Plus defibrillator | Premature battery depletion due to electrical component failure | accessdata.fda.gov |
| August 30, 2006 | 36190 | Not yet classified | Terminated | LIFEPAK 20 external defibrillator/monitor | Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning. | accessdata.fda.gov |
| March 22, 2006 | 34947 | Not yet classified | Terminated | LIFEPAK 12 defibrillator/monitor | Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. | accessdata.fda.gov |
| March 16, 2006 | 36493 | Not yet classified | Terminated | LIFEPAK 20 automatic external defibrillator | LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. | accessdata.fda.gov |
| February 1, 2006 | 34533 | Not yet classified | Terminated | LIFEPAK 500 automated external defibrillator (AED) | Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative. | accessdata.fda.gov |
| January 31, 2006 | 34534 | Not yet classified | Terminated | LIFEPAK CR Plus defibrillator | One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. | accessdata.fda.gov |
| September 2, 2005 | 33327 | Not yet classified | Terminated | QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series. | Potential for voltage pins in connector of therapy cable to break. | accessdata.fda.gov |
| July 12, 2005 | 32642 | Not yet classified | Terminated | Hard shell carry case for the LIFEPAK 500 AED. | Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent). | accessdata.fda.gov |
| June 17, 2005 | 32492 | Not yet classified | Terminated | LIFEPAK 20 defbrillator/monitor | The defibrillator may not operate if the device is turned on during an AC Loss Alert. | accessdata.fda.gov |
| February 3, 2005 | 31111 | Not yet classified | Terminated | LIFEPAK 500 AED. | Potential to not detect patients at the low end of the patient impedance range. | accessdata.fda.gov |
| January 15, 2005 | 30915 | Not yet classified | Terminated | LIFEPAK 12 defibrillator/ monitors biphasic | The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. | accessdata.fda.gov |
| May 5, 2004 | 29027 | Not yet classified | Terminated | DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor. | The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor. | accessdata.fda.gov |
| May 5, 2004 | 29025 | Not yet classified | Terminated | LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVL | Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage. | accessdata.fda.gov |
| April 5, 2004 | 28737 | Not yet classified | Terminated | LIFEPAK 12 defibrillator/monitor. | Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator. | accessdata.fda.gov |
| April 2, 2004 | 28727 | Not yet classified | Terminated | LIFEPAK 500 automated external defibrillator | Potential for batteries to malfunction due to battery cell rupture. | accessdata.fda.gov |
| November 12, 2003 | 27864 | Not yet classified | Terminated | LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20. | Device unable to recognize the connection to the hard paddles accessory. | accessdata.fda.gov |
| May 23, 2003 | 26358 | Not yet classified | Terminated | LIFEPAK CR Plus defibrillator | Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy. | accessdata.fda.gov |
| January 27, 2003 | 25289 | Not yet classified | Terminated | LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually | Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit. | accessdata.fda.gov |
Compare with other makers
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- All makers of Computer, Blood-Pressure
Updated May 4, 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.