LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507 (REF 99507-000001)Recalls & reported problems

Physio-Control, Inc. · LP20E - CONFIGURED,AHA 2005, LI-ION, ENGLISH · Class 3

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

Data updated Oct 18, 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.

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873813751), received between Jul 30, 2019 and Apr 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

16 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.

Recalls naming this device

Feb 3, 2025Class IIOpen, Classified
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Z-1232-2025 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Power Up2
Electrical /Electronic Property Problem1
Power Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 1, 2022Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT TURNING ON WITH AC OR DC POWER. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978355 ↗
MalfunctionFeb 11, 2021Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11318977 ↗
MalfunctionJul 30, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THEIR DEVICE WAS INTERMITTENTLY POWER CYCLING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8843663 ↗

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-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-0300-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Z-0298-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Z-0303-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Z-0299-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Z-0297-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Z-0302-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Z-0301-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Z-0296-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Z-0304-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023

…and 1 more.

Device details

UDI-DI	`00883873813751`
Brand	LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
Model	99507
Catalog no.	99507-000001
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

NA 861290
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
12 deaths5,167 reports
NA 861288
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
21 deaths5,015 reports
NA 861289
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
7 deaths3,385 reports
R SERIES 30001005201310012
Zoll Medical Corporation · Automated external defibrillators (non-wearable)
10 deaths1,720 reports
PHILIPS HeartStart FRx
Philips Electronics North America Corporation · Automated external defibrillators (non-wearable)
26 deaths1,586 reports
LIFEPAK CR2 99512
Physio-Control, Inc. · Automated external defibrillators (non-wearable)
8 deaths1,502 reports
Lifeline Configuration DDU-100A
Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)
1 death1,285 reports
PHILIPS HeartStart FR3
Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)
10 deaths1,188 reports

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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