Physio-Control Corp.
Medical device manufacturer in Redmond, WA.
94510(k) clearances
3PMA approvals
72recalls
Device types
- MKJ Automated External Defibrillators… 18
- LDD Dc-Defibrillator, Low-Energy, (Including… 17
- DRO Pacemaker, Cardiac, External Transcutaneous… 10
- DPS Electrocardiograph 5
- DXN System, Measurement, Blood-Pressure… 5
- DRX Electrode, Electrocardiograph 5
- DXH Transmitters And Receivers, Electrocardiogra… 5
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 3
- DSF Recorder, Paper Chart 3
- KLA Monitor, Esophageal Motility, Anorectal… 2
- KDJ Set, Administration, For Peritoneal… 2
- IOL Treadmill, Powered 2
- MSX System, Network And Communication… 2
- DRW Adaptor, Lead Switching, Electrocardiograph 1
- BZN Cart, Emergency, Cardiopulmonary (Excluding… 1
- DJC Thin Layer Chromatography, Methamphetamine 1
- DRL Tester, Defibrillator 1
- DSH Recorder, Magnetic Tape, Medical 1
- FKX System, Peritoneal, Automatic Delivery 1
- MPD Auxiliary Power Supply (Ac Or Dc) For… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333)MPD · Special | 10/14/2025SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | 04/30/2024SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | 06/03/2019SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | 12/19/2014SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | 08/21/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
| K093925 | Lifenet SystemMSX · Special | 01/12/2010SE |
| K082937 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/11/2009SE |
| K073089 | Lifepak 20EMKJ · Traditional | 07/29/2008SE |
| K991910 | Lifepak 12 BiphasicMKJ · Traditional | 09/03/1999ST |
| K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemDXN · Traditional | 09/01/1999SE |
| K983393 | Lifepak 500 BiphasicMKJ · Traditional | 05/05/1999ST |
| K973486 | Life Pak 12MKJ · Traditional | 01/09/1998SE |
| K962359 | Lifepak 300MKJ · Traditional | 11/06/1997SE |
| K955854 | Lifepak 500MKJ · Traditional | 11/04/1996SE |
| K953204 | Pediatric Quik-ComboMKJ · Traditional | 01/11/1996SE |
| K951593 | Lifepak 11DRO · Traditional | 12/29/1995SE |
| K945511 | Lifepak 10 Defibrillator/Monitor/Pacemaker, and Lifepak 11 Cardiac MonitorMPE · Traditional | 09/26/1995SE |
| K943301 | Quik ComboDRX · Traditional | 02/03/1995SE |
| K941970 | Fast-PatchMKJ · Traditional | 12/07/1994SE |
| K925936 | Lifepak 300 Automatic Advisory DefrillatorMKJ · Traditional | 06/08/1994SE |
| K922315 | Vital-Combo(R)LDD · Traditional | 03/16/1994SE |
| K935674 | Lifepak 9 Defibrillator/MonitorLDD · Traditional | 12/16/1993SE |
| K931053 | Lifepak 10 Defibrillator/Monitor W/Opt PacemakerLDD · Traditional | 05/18/1993SE |
| K912966 | Pediatric Disposable External Defibrilation/EcgLDD · Traditional | 02/21/1992SE |
| K912189 | Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationLOS · Traditional | 02/14/1992SE |
| K912599 | Quik-Pace(R) or Ex-Pace(Tm) Pediatric Pacing ElecDRO · Traditional | 09/11/1991SE |
| K910144 | 12-LEAD ECG Adaptor for Use W/Lifepak 10 Defib/MonLDD · Traditional | 07/17/1991SE |
| K902288 | Modified Lifepak 9 Monitor/DefibrillatorLDD · Traditional | 02/25/1991SE |
| K905510 | Lifepak 9 Defibrillator & Cardiac Monitor/ModifiedLDD · Traditional | 12/20/1990SE |
| K902478 | Lifepak 300 Automatic Advisory DefibrillatorLDD · Traditional | 10/31/1990SE |
| K895379 | Low Energy DC - Defibrillator (Including Paddles)LDD · Traditional | 02/26/1990SE |
| K894540 | Telemetry Receiver Accessory for the CMS 8000DXH · Traditional | 10/12/1989SE |
| K892005 | Shock Advisory Adapter for Use W/Lifepak 9MKJ · Traditional | 06/20/1989SE |
| K892065 | Lifepak 250 Defibrillator/MonitorMKJ · Traditional | 06/05/1989SE |
| K890079 | Lifepak 10 Defibrillator/MonitorLDD · Traditional | 02/23/1989SE |
| K883617 | Lifepak 50 Monitor/DefibrillatorLDD · Traditional | 12/28/1988SE |
| K883121 | Quik-Pace II ElectrodesDRO · Traditional | 09/20/1988SE |
| K881153 | Lifepak 9 Defibrillator and Cardiac MonitorLDD · Traditional | 07/27/1988SE |
| K881346 | Lifestat 1600 PrinterDSF · Traditional | 06/09/1988SE |
| K880554 | Vsm(R) R2 Paper Chart RecorderDSF · Traditional | 05/06/1988SE |
| K871751 | Quik-Pace Noninvasive PacemakerDRO · Traditional | 12/29/1987SE |
| K871224 | Fast-Patch(Tm)LDD · Traditional | 05/20/1987SE |
| K864666 | Modified Lifestat 200DXN · Traditional | 12/11/1986SE |
| K864665 | Modified VSM 2 Vital Signs MonitorDXN · Traditional | 12/11/1986SE |
| K853561 | Lifestat 100DXN · Traditional | 06/09/1986SE |
| K855027 | Pulse OximeterDQA · Traditional | 05/16/1986SE |
| K853096 | CMS 8000DXH · Traditional | 01/22/1986SE |
| K854117 | Amendment Lifepak 8, NPN 052DRO · Traditional | 01/13/1986SE |
| K853732 | Lifepak 8 ModificationDRO · Traditional | 12/09/1985SE |
| K853564 | Lifepak 200MKJ · Traditional | 10/11/1985SE |
| K852322 | VSM-5DPS · Traditional | 09/11/1985SE |
| K851916 | VSM Models a & BDRT · Traditional | 08/19/1985SE |
| K851248 | Amendment Lifepak 100, NPN 045DRO · Traditional | 04/19/1985SE |
| K851247 | Amendment Lifepak 200, NPN 046DRO · Traditional | 04/19/1985SE |
| K842213 | VSM R1DXO · Traditional | 10/26/1984SE |
| K832833 | Personal DefibrillatorLDD · Traditional | 10/26/1984SE |
| K843229 | Lifepak 200LDD · Traditional | 10/18/1984SE |
| K842624 | Lifepak 8LDD · Traditional | 10/18/1984SE |
| K840047 | Lifepak 7DDRO · Traditional | 02/04/1984SE |
| K833584 | Vital Signs Monitor 3DPS · Traditional | 01/30/1984SE |
| K832876 | Lifepak 7PDRO · Traditional | 01/30/1984SE |
| K831232 | Lifestat 200DXN · Traditional | 07/28/1983SE |
| K830587 | Vital Signs Monitor 2DRT · Traditional | 06/08/1983SE |
| K810154 | Lifepak 7 Acute Cardiac Care SystemDPS · Traditional | 03/26/1981SE |
| K800492 | VSM-1 Physiological MonitorDPS · Traditional | 03/18/1980SE |
| K792380 | CMS 6000GYE · Traditional | 01/04/1980SE |
| K791342 | ADR-10600(ADR 400),10601 (Adr 300)FKX · Traditional | 11/16/1979SE |
| K791003 | ECG Electrodes, Pediatric-Microporous TaDRX · Traditional | 06/01/1979SE |
| K791002 | ECG Electrodes, Pediatric-Foam TapeDRX · Traditional | 06/01/1979SE |
| K790757 | Lifepak 5 Monitor, Cassette, #800923-01DSH · Traditional | 06/01/1979SE |
| K790959 | Lifepatch ECG ElectrodesDRX · Traditional | 05/31/1979SE |
| K790394 | Defibrillator Interal Paddle Test LoadDRL · Traditional | 03/23/1979SE |
| K781156 | Dialysis Sys., PDS 400 & Ro 400DJC · Traditional | 10/24/1978SE |
| K780082 | Peritoneal Dialysis Admin. SetKDJ · Traditional | 01/24/1978SE |
| K772320 | Emergency CartBZN · Traditional | 01/03/1978SE |
| K772136 | Peritoneal Cycler & Manifold SetKDJ · Traditional | 12/20/1977SE |
| K772006 | Acute Cardiac Care SystemDRT · Traditional | 11/28/1977SE |
| K771723 | Hill TubeKLA · Traditional | 11/22/1977SE |
| K771265 | Pressure Monitor Manometric Sys.KLA · Traditional | 11/22/1977SE |
| K770083 | Lifepatch TM ECG ElectrodeDRX · Traditional | 02/01/1977SE |
| K761210 | Limb Lead Sel. (ECG Lead Switching Ad.)DRW · Traditional | 12/21/1976SE |
| K761066 | ECG Monitor (Telephone ECG Transmitter)DXH · Traditional | 12/09/1976SE |
| K761041 | Powered Treadmill (30/ST)IOL · Traditional | 12/09/1976SE |
| K761040 | Powered Treadmill (20/ST)IOL · Traditional | 12/09/1976SE |
| K760724 | Peritoneal Dialysis SystemEKX · Traditional | 11/23/1976SE |
| K760676 | Lifepak 5 Cardioscope-Recorder ModuleDSF · Traditional | 10/13/1976SE |
| K760677 | Lifepak 5 Cardioscope Module (NPN 5)DPS · Traditional | 10/05/1976SE |
| K760564 | Demodulator Series 1400DXH · Traditional | 09/10/1976SE |
| K760563 | ECG ModulatorDXH · Traditional | 09/10/1976SE |
PMA approvals
- P170018 LIFEPAK® CR2 Defibrillator · 12/21/2018 · 25 supplements
- P160026 Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak 15 Monitor/De · 07/02/2018 · 70 supplements
- P160012 LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger · 12/21/2017 · 6 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2065-2026 Class II | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241…Some defibrillators serviced between July 2023 through November 2025 were serviced without objective… | 04/13/2026Open, Classified |
| Z-1544-2026 Class II | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers:…Due to pediatric defibrillator electrode delamination | 01/21/2026Open, Classified |
| Z-2499-2025 Class II | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911…Due to required inspections not being performed on products/units that have gone through servicing. | 07/22/2025Open, Classified |
| Z-2498-2025 Class II | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 /…Due to required inspections not being performed on products/units that have gone through servicing. | 07/22/2025Open, Classified |
| Z-2497-2025 Class II | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 /…Due to required inspections not being performed on products/units that have gone through servicing. | 07/22/2025Open, Classified |
| Z-1232-2025 Class II | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in…Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | 02/03/2025Open, Classified |
| Z-1184-2025 Class II | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet…Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin… | 01/21/2025Open, Classified |
| Z-1102-2025 Class II | LIFEPAK 35 ECG cable REF 11111-000041Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | 01/21/2025Open, Classified |
| Z-0230-2025 Class II | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o…Due to an out of tolerance tool being used on monitor/defibrillator systems. | 08/30/2024Open, Classified |
| Z-0142-2025 Class II | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL…Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of… | 08/09/2024Open, Classified |
| Z-0567-2024 Class II | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the… | 11/06/2023Open, Classified |
| Z-0305-2024 Class II | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0304-2024 Class II | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0303-2024 Class II | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0302-2024 Class II | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0301-2024 Class II | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0300-2024 Class II | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0299-2024 Class II | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0298-2024 Class II | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0297-2024 Class II | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0296-2024 Class II | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0745-2022 Class III | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-PakSemi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | 01/13/2022Terminated |
| Z-1189-2021 Class II | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is…Due to complaints received regarding missing lid magnets which may result in premature battery depletion. | 01/14/2021Open, Classified |
| Z-2360-2020 Class II | Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced…Packaging of infant child reduced energy electrodes was not properly sealed. | 04/24/2020Terminated |
| Z-2359-2020 Class II | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use…Packaging of infant child reduced energy electrodes was not properly sealed. | 04/24/2020Terminated |
| Z-1633-2020 Class II | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX…Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the… | 03/20/2020Terminated |
| Z-0817-2020 Class II | LIFEPAK 15 MONITOR/DEFIBRILLATOR service kitsMonitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result… | 12/20/2019Terminated |
| Z-0816-2020 Class II | LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an…Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result… | 12/20/2019Terminated |
| Z-0863-2019 Class I | LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15…Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was… | 02/01/2019Terminated |
| Z-0862-2019 Class I | LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator…Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was… | 02/01/2019Terminated |
| Z-0294-2018 Class I | LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e…Physio-Control is aware that some devices have had power-related failures as customers prepared their device… | 12/04/2017Terminated |
| Z-0187-2018 Class I | LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The…The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type… | 10/27/2017Terminated |
| Z-0186-2018 Class I | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The…The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type… | 10/27/2017Terminated |
| Z-1144-2017 Class II | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained…The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device… | 01/16/2017Terminated |
| Z-1143-2017 Class II | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in…The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device… | 01/16/2017Terminated |
| Z-1257-2017 Class I | The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a…The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during… | 01/13/2017Terminated |
| Z-1123-2017 Class I | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and…The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to… | 01/12/2017Terminated |
| Z-2100-2016 Class II | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are…LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice… | 05/25/2016Terminated |
| Z-1993-2016 Class II | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part…The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is… | 01/27/2016Terminated |
| Z-1660-2014 Class II | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode)…Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000… | 05/09/2014Terminated |
| Z-1773-2013 Class II | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that…The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an… | 06/12/2013Terminated |
| Z-1082-2013 Class II | The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers:…LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the… | 02/08/2013Terminated |
| Z-2885-2011 | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that…The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access… | 06/06/2011Terminated |
| Z-2625-2011 | 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with…The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break… | 05/11/2011Terminated |
| Z-1548-2011 | The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in…L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall)… | 10/01/2010Terminated |
| Z-1903-2010 | LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx…A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure… | 05/27/2010Terminated |
| Z-1722-2011 | The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx…A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC… | 05/27/2010Terminated |
| Z-0761-2017 Class II | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in…Customer complaint was received relating to a LifePak15 device that would power on then power down… | 03/11/2010Terminated |
| Z-1410-2010 | Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a…Potential for the device to power off then on by itself, or to power off by itself and requiring the… | 03/04/2010Terminated |
| Z-2110-2009 | Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor…Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by… | 08/12/2009Terminated |
| Z-2030-2009 | Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external…The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly… | 07/31/2009Terminated |
| Z-0811-2010 | Biphasic LIFEPAK 12 defibrillator / monitor.Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could… | 03/31/2009Terminated |
| Z-1171-2009 | Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use…Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product… | 02/16/2009Terminated |
| Z-0185-2012 | The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with…When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the… | 12/30/2008Terminated |
| Z-2312-2010 | Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK…Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and… | 11/17/2008Terminated |
| Z-2311-2010 | External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and…Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and… | 11/17/2008Terminated |
| Z-2341-2008 | LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public…This recall is being conducted due to the device being configured with the incorrect software for… | 08/28/2008Terminated |
| Z-0150-2009 | LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states…The device may not power on although it indicates it is ready for use and would not be able to provide… | 07/24/2008Terminated |
| Z-0149-2009 | LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states…The device may not power on although it indicates it is ready for use and would not be able to provide… | 07/24/2008Terminated |
| Z-2388-2008 | Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of…Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect… | 06/18/2008Terminated |
| Z-2011-2008 | Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator.A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed… | 05/13/2008Terminated |
| Z-2010-2008 | Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external…A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed… | 05/13/2008Terminated |
| Z-2009-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external…A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is… | 05/13/2008Terminated |
| Z-1858-2008 | Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor…The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on… | 05/08/2008Terminated |
| Z-1906-2008 | Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is…The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an… | 04/16/2008Terminated |
| Z-1905-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of…The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in… | 04/16/2008Terminated |
| Z-1904-2008 | Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of…The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an… | 04/16/2008Terminated |
| Z-1656-2008 | LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be…Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in… | 02/27/2008Terminated |
| Z-1567-2008 | FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd…Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries. | 02/27/2008Terminated |
| Z-2036-2008 | Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or… | 01/29/2008Terminated |
| Z-2035-2008 | Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12…Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or… | 01/29/2008Terminated |
| Z-1050-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with…Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion… | 01/08/2008Terminated |