The Recall Desk
HighFDA (Devices)·Z-0300-2024·Announced 2023-11-22

LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

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 with a theoretical hazard (loose battery pins causing power loss) but no reported incidents or injuries. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (REF: 99577-001373, Part Number V15-7-000002) due to a potential defect in the battery connection.

The recall addresses a potential issue where battery pins may become loose within the defibrillator, which could result in power issues that may prevent proper device operation.

Affected units were distributed nationwide, with documented distribution in Arizona, California, North Carolina, New Jersey, and New York.

The recalled product

Product
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Manufacturer
Physio-Control, Inc.
Hazard
  • battery-defect
  • 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: 00883873884331/ Serial number: 49618486

Distribution

Distributed nationwide across the United States.