LIFEPAK 15 monitor/defibrillator 97577 (REF 97577-000101)Recalls & reported problems

Physio-Control, Inc. · 15AACBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB · Class 3

All models of LIFEPAK 15 monitor/defibrillator (93)

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: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00883873808214), received between May 12, 2022 and Jan 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (1 report).

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.

Reports received per month

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

Recalls naming this device

Aug 30, 2024Class IIOpen, Classified
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Z-0230-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Power Up1
Unexpected Shutdown1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 18, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF WHILE MONITORING A PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18533067 ↗
MalfunctionMay 12, 2022Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS INTERMITTENTLY NOT POWERING ON. 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 14375937 ↗

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-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-0299-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Z-0301-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Z-0302-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Z-0298-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Z-0304-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Z-0303-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Z-0305-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Z-0296-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

…and 1 more.

Device details

UDI-DI	`00883873808214`
Brand	LIFEPAK 15 monitor/defibrillator
Model	97577
Catalog no.	97577-000101
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.

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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 · 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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