The Recall Desk
HighFDA (Devices)·Z-0303-2024·Announced 2023-11-22

LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

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 is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a potential for battery pins to become loose. Per the severity rubric, when no illnesses or injuries have been reported and the hazard is theoretical, the maximum score is 3. The device's critical function justifies High severity despite the lack of confirmed incidents.

Plain-English summary

Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator, model reference 99577-001957, part numbers V15-5-000586 and V15-7-000022. Eight units identified by the serial numbers provided in the recall notice are included in this recall.

Battery pins within these devices may become loose, potentially resulting in power loss. A defibrillator experiencing power loss may be unable to function properly if needed in an emergency.

The affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York. Consumers who believe they possess an affected device should verify the serial number against the official FDA recall notice for further guidance.

The recalled product

Product
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Manufacturer
Physio-Control, Inc.
Hazard
  • battery-failure
  • power-loss

Distribution

Distributed nationwide across the United States.