NA 11140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873940204), received between Aug 14, 2024 and Aug 14, 2024 — classified as 1 malfunction.

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.

7 other recalls cover devices cleared under the same FDA submission (K142430); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 6, 2023Open, Classified

   AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

   Z-0567-2024 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE EXPERIENCED A COMPLETE FAILURE. 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 19983572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142430. One submission often covers many models, so check the product and lot details in each record.

• Z-0816-2020 · Dec 20, 2019 · Terminated
  LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
• Z-0817-2020 · Dec 20, 2019 · Terminated
  LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
• Z-0863-2019 · Feb 1, 2019 · Terminated
  LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic lif
• Z-0862-2019 · Feb 1, 2019 · Terminated
  LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BL
• Z-1144-2017 · Jan 16, 2017 · Terminated
  LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environ
• Z-1123-2017 · Jan 12, 2017 · Terminated
  LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external de
• Z-1993-2016 · Jan 27, 2016 · Terminated
  LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues soft