LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507 (REF 99507-000016)Recalls & reported problems

Physio-Control, Inc. · LP20E-CONFIGURED, AHA 2005, PACE, MNC SPO2, ENG · Class 3

All models of LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors (23)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This LIFEPAK 20 defibrillator monitor is used for emergency heart defibrillation. Many of the 124 reports describe the device failing to power on, electrical problems, or failing to analyze the heart rhythm, and most list no clinical signs for the patient. The reports include no deaths and no injuries. No recalls name this device.

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: 124
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00883873813829), received between Jan 21, 2019 and Aug 18, 2025 — classified as 124 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (43 reports).

17 other recalls cover devices cleared under the same FDA submission (P160026); 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Electrical /Electronic Property Problem43
Failure to Power Up27
Failure to Sense7
Inappropriate/Inadequate Shock/Stimulation7
Display or Visual Feedback Problem6
Failure to Charge6
Connection Problem5
Energy Output Problem5

Patient problems

No Clinical Signs, Symptoms or Conditions105
No Patient Involvement21
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED THAT THE DEVICE WOULD NOT COMPLETE ITS BOOT UP CYCLE. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22832031 ↗
MalfunctionDec 30, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21035041 ↗
MalfunctionDec 27, 2024Failure to Analyze Signal; Failure to Analyze Signal
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT ANALYZE ANY HEART RHYTHM USING THE PADDLES LEAD. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21029717 ↗
MalfunctionOct 14, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439574 ↗
MalfunctionJul 24, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE "DID NOT SHOCK DURING PATIENT THERAPY". THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822744 ↗
MalfunctionJul 16, 2024Failure to Sense; Inappropriate/Inadequate Shock/Stimulation; Failure to Sense; Inappropriate/Inadequate Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT RECOGNIZE THE INTERNAL PADDLE AND UNABLE TO DELIVER APPROPRIATE ENERGY. 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 19749368 ↗
MalfunctionJul 15, 2024Failure to Deliver Shock/Stimulation; Key or Button Unresponsive/not Working; Failure to Deliver Shock/Stimulation; Key or Button Unresponsive/not Working
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE DEFIBRILLATION THERAPY BECAUSE THE SYNC BUTTON WAS JAMMED. AS A RESULT, DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746884 ↗
MalfunctionJul 9, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON USING AC POWER. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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 19706322 ↗
MalfunctionJul 1, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON. 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 19643112 ↗
MalfunctionApr 26, 2024Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, STRYKER OBSERVED THAT THE ECG WOULD NOT BE OBTAINABLE THROUGH PADDLES LEAD. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19189792 ↗
MalfunctionApr 25, 2024Energy Output Problem; Energy Output Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEVICE ONLY DELIVERED A SHOCK OF 79 JOULES AT A SELECTED ENERGY LEVEL OF 200 JOULES. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19178646 ↗
MalfunctionApr 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY WAS BLANK. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19027303 ↗
MalfunctionMar 21, 2024Energy Output Problem; Energy Output Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHOWED AN "ABNORMAL ENERGY DELIVERY" WARNING DURING A PATIENT EVENT. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY HAVE BEEN DELIVERED TO THE PATIENT, IF NEEDED. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18950498 ↗
MalfunctionMar 7, 2024Failure to Sense; Failure to Sense
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE CONTINUED TO PACE DURING TESTING WITH ONE PAD REMOVED. 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 18855715 ↗
MalfunctionFeb 29, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT POWER WITH AC OR DC. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18810752 ↗
MalfunctionFeb 8, 2024Failure to Charge; Failure to Deliver Shock/Stimulation; Failure to Charge; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT CHARGE WHEN THEY ATTEMPTED TO PROVIDE DEFIBRILLATION TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18667732 ↗
MalfunctionFeb 8, 2024Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18666635 ↗
MalfunctionDec 11, 2023Failure to Charge; Failure to Deliver Shock/Stimulation; Failure to Charge; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THAT THEIR DEVICE DID NOT PROVIDE DEFIBRILLATION ENERGY DURING PATIENT CARE. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18303815 ↗
MalfunctionDec 5, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268147 ↗
MalfunctionNov 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAY A BLANK WHITE SCREEN. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18183732 ↗
MalfunctionNov 21, 2023Failure to Charge; Failure to Charge
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DEFIBRILLATION ENERGY CHARGE IS INOPERATIVE ON THEIR DEVICE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182770 ↗
MalfunctionOct 26, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18013135 ↗
MalfunctionSep 26, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON. 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 17816869 ↗
MalfunctionAug 14, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED A BLANK SCREEN. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17539687 ↗
MalfunctionJul 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE'S SCREEN WAS BLANK. IN THIS STATE THE DEVICE WOULD 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 17314914 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160026. One submission often covers many models, so check the product and lot details in each record.

Z-2065-2026 · Apr 13, 2026 · Open, Classified
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, 99577-001
Z-2497-2025 · Jul 22, 2025 · Open, Classified
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 V
Z-2498-2025 · Jul 22, 2025 · Open, Classified
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953
Z-1232-2025 · Feb 3, 2025 · Open, Classified
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Z-1184-2025 · Jan 21, 2025 · Open, Classified
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 Sen
Z-0230-2025 · Aug 30, 2024 · Open, Classified
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 99
Z-0567-2024 · Nov 6, 2023 · Open, Classified
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Z-0304-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Z-0305-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Z-0302-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Z-0303-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Z-0297-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Z-0296-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Z-0300-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Z-0299-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

…and 2 more.

Device details

UDI-DI	`00883873813829`
Brand	LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
Model	99507
Catalog no.	99507-000016
Company	Physio-Control, Inc.
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	P160026
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 18, 2020

Device type (GMDN): Physiologic-monitoring defibrillation system

An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

Other Automated external defibrillators (non-wearable) devices

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NA 861288
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NA 861289
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R SERIES 30001005201310012
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PHILIPS HeartStart FRx
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All Automated external defibrillators (non-wearable) devices →

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
Page last rebuilt: Oct 18, 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