LIFEPAK 99512 (REF 99512-001434)Recalls & reported problems
Physio-Control, Inc. · LPCR2,USB,H,EN-US,DE,A,1,MODET,FLX,CPR120,A104:0,P30:2,200J,300J,360J,50J,75J,90J,ALRT,US · Class 3
All models of LIFEPAK (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker LIFEPAK 99512 automated external defibrillator is a non-wearable shock device used in emergencies. Reports mostly describe the unit failing to power up on its own — often because the magnet in the lid was missing or damaged — plus detached parts, damaged defibrillation pads, and one unit that would not analyze heart rhythms. There are 33 reports, with no deaths and no injuries. One recall began in July 2025 and remains open, because required inspections were not performed on units that had been serviced.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00883873785911), received between Oct 9, 2020 and Jun 1, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (P170018); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Jul 22, 2025Open, Classified
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2499-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component19
- Failure to Power Up9
- No Audible Prompt/Feedback2
- Power Problem2
- Audible Prompt/Feedback Problem1
- Failure to Analyze Signal1
- Failure to Deliver Energy1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT, DURING THEIR DEVICE INSTALLATION, THEY OBSERVED THE DEFIBRILLATION ELECTRODES WERE DAMAGED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349505 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LED TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035613 ↗MalfunctionAug 13, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE WAS NOT ABLE TO POWER ON WHEN THE LID WAS OPENED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977072 ↗MalfunctionJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE WAS MISSING ITS LID MAGNET. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19850982 ↗MalfunctionJul 19, 2024Failure to Analyze Signal; Failure to Analyze Signal
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT ANALYZE ECG RHYTHM. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19780495 ↗MalfunctionMay 19, 2024Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED THAT THE DEVICE WOULD NOT DETECT THE LID BEING OPENED AND WOULD NOT POWER ON. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19348569 ↗MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19211266 ↗MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744766 ↗MalfunctionFeb 6, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE DOESN'T POWER ON WHEN THE LID IS OPENED. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655900 ↗MalfunctionJan 24, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE INTERMITTENTLY WOULD NOT POWER ON WHEN THE LID IS OPENED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18569454 ↗MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18504413 ↗MalfunctionJan 10, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE WOULD NOT POWER ON WHEN THE DEVICE LID WAS ACTIVATED. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18487355 ↗MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366647 ↗MalfunctionDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320158 ↗MalfunctionNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USERS HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18088810 ↗MalfunctionNov 1, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE DID NOT TURN AS EXPECTED WHEN OPENING THE LID. IN THIS STATE A USE ERROR COULD OCCUR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18047995 ↗MalfunctionOct 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18001741 ↗MalfunctionOct 13, 2023No Audible Prompt/Feedback; Detachment of Device or Device Component; No Audible Prompt/Feedback; Detachment of Device or Device Component
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET AND WOULD NOT PROVIDE AUDIO PROMPTS. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929872 ↗MalfunctionMay 24, 2023Detachment of Device or Device Component; Audible Prompt/Feedback Problem; Detachment of Device or Device Component; Audible Prompt/Feedback Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNETIC PIN IN THE LID AND THERE WERE NO VOICE PROMPTS. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY AND DELIVER AUDIBLE INSTRUCTIONS, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16990599 ↗MalfunctionMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954189 ↗MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNETIC PIN IN THE LID. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16867681 ↗MalfunctionMar 9, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WITH A NEW BATTERY INSTALLED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16518427 ↗MalfunctionJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16255066 ↗MalfunctionJan 18, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194796 ↗MalfunctionNov 11, 2022Failure to Deliver Energy; Inappropriate or Unexpected Reset; Failure to Deliver Energy; Inappropriate or Unexpected Reset
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE UNEXPECTEDLY POWER CYCLED DURING TESTING AND GAVE A "ENERGY NOT DELIVERED" MESSAGE WHEN A SHOCK WAS DELIVERED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15784541 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P170018. One submission often covers many models, so check the product and lot details in each record.
- Z-1189-2021 · Jan 14, 2021 · Open, ClassifiedPHYSIO 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
Other Automated external defibrillators (non-wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page