LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to 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 of a critical medical device with a potential power failure hazard due to loose battery pins. No injuries or illnesses have been reported to date, placing it in the High severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator (Part Numbers V15-5-000584 and V15-7-000020, UDI: 00883873871713) due to a potential defect in the battery pin assembly. Four units with the following serial numbers are affected: 44174756, 46013280, 46966395, and 48149013.
The hazard exists because battery pins within the defibrillator may become loose, which could result in power issues and prevent the device from functioning properly during emergency use.
The affected units were distributed to medical facilities in Arizona, California, North Carolina, New Jersey, and New York. Healthcare providers and consumers who possess one of the affected serial numbers should stop using the device and contact Physio-Control for replacement or repair instructions. No injuries or illnesses have been reported.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- loose-battery-pins
- 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 (4)
- UDI: 00883873871713/ Serial number: 44174756
- 46013280
- 46966395
- 48149013
Distribution
Distributed nationwide across the United States.
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