LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins
Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.
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-use medical device with potential for power loss. No illnesses or injuries have been reported, and the hazard is explicitly theoretical ("potential for"), meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator (REF: 99577-001958, Part Number: V15-7-000023, Serial number: 48839976). This is an FDA Class II recall.
The device has a potential defect where battery pins may become loose within the defibrillator, which could result in power loss. This could prevent the device from functioning properly when needed for emergency response.
The affected unit was distributed in Arizona, California, North Carolina, New Jersey, and New York.
Anyone who owns or operates this device should contact Physio-Control, Inc. for instructions on how to address this issue.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- battery-malfunction
- 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: 00883873871683/ Serial number: 48839976
Distribution
Distributed nationwide across the United States.
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