LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure
Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.
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 a risk-of-harm medical device (defibrillator) where failure during use could be life-threatening. However, no illnesses or injuries have been reported, and the hazard is characterized as potential rather than confirmed. FDA Class II classification indicates moderate regulatory concern. Score 3 reflects the serious consequences of device failure in a cardiac emergency setting, balanced against the absence of reported harm.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator (Model 99577-000061, Part Number V15-2-000067) nationwide. The recall affects units distributed in Arizona, California, North Carolina, New Jersey, and New York.
The defibrillator may experience power failure due to loose battery pins within the device. This could prevent the unit from functioning when needed in a cardiac emergency.
The affected unit has Serial Number 38166543 (UDI: 00883873979358). No injuries or illnesses have been reported to date.
Users should verify the functionality of their LIFEPAK 15 devices and contact Physio-Control for guidance on inspection or replacement.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- battery-malfunction
- power-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 (1)
- UDI: 00883873979358/ Serial number: 38166543
Distribution
Distributed nationwide across the United States.
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