The Recall Desk
HighFDA (Devices)·Z-0567-2024·Announced 2023-12-27

AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On

AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall affects a life-critical medical device (defibrillator) with a functional defect that prevents charging and normal operation. While no illnesses or injuries have been reported, the risk of harm is significant given the critical emergency-response function of the device. Per the severity rubric, this qualifies as a high-risk product where injury has not yet been reported.

Plain-English summary

Physio-Control, Inc. is recalling AC Power Adapters (Reference 11140-000098) for LIFEPAK 15 Monitor/Defibrillator units manufactured between November 3, 2021 and April 24, 2023. Approximately 18,732 units have been distributed nationwide across all 50 states and Puerto Rico.

The affected AC power adapters may fail to charge the monitor/defibrillator batteries and may not allow the device to power on while plugged in. This functional defect could prevent critical patient monitoring and defibrillation capabilities during emergency situations.

Healthcare facilities and patients using affected LIFEPAK 15 systems should immediately discontinue use of the recalled AC power adapters. Contact Physio-Control for replacement units. The FDA recall is numbered Z-0567-2024 and the affected adapters carry UDI-DI 00883873940204.

The recalled product

Product
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Manufacturer
Physio-Control, Inc.
Hazard
  • device-malfunction
  • charging-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 00883873940204
  • Adapters manufactured between 11/3/2021 - 4/24/2023

Distribution

Distributed nationwide across the United States.