The Recall Desk
HighFDA (Devices)·Z-0299-2024·Announced 2023-11-22

LIFEPAK 15 defibrillator recalled for potential battery power loss

Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

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: FDA Class II recall of a critical life-saving medical device where a potential defect could result in power loss during emergency use. No illnesses or injuries have been reported, but the hazard poses significant risk of harm given the device's critical function.

Plain-English summary

Physio-Control, Inc. is recalling 5 LIFEPAK 15 defibrillators (Part Number V15-2-001602, REF: 99577-001255) due to a potential defect where battery pins may become loose within the device. This condition could result in power loss during operation.

Affected units were distributed nationwide in Arizona, California, North Carolina, New Jersey, and New York. The recall applies to units with the following serial numbers: 40644322, 40644323, 40644331, 42221204, and 42934131.

No illnesses or injuries related to this issue have been reported. If you have one of the affected units, contact Physio-Control, Inc. immediately for guidance on inspection, repair, or replacement.

The recalled product

Product
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Manufacturer
Physio-Control, Inc.
Hazard
  • battery-pin-loosening
  • power-loss

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 (1)

  • UDI: 00883873911648/ Serial number: 40644322 40644323 40644331 42221204 42934131

Distribution

Distributed nationwide across the United States.