LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 life-saving medical device where loose battery pins could prevent operation during emergencies. Although no illnesses or injuries have been reported, it qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criteria.
Plain-English summary
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (REF: 99577-001956, Part Number V15-7-000021). There is a potential for battery pins to become loose within the defibrillator, which could result in power issues.
If battery pins become loose, the defibrillator may not operate properly. This is of concern because defibrillators are critical life-saving devices used during cardiac emergencies.
The affected device has been distributed nationwide in Arizona, California, North Carolina, New Jersey, and New York.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 1
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: 00883873871706/ Serial number: 46687975
Distribution
Part of a larger recall action
This product is one of 10 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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Similar recalls
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