LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss
Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.
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 with no reported illnesses or injuries. The hazard is theoretical—a potential for battery pins to become loose. Per the severity rubric, when no illnesses or injuries have been reported and the hazard is theoretical, the maximum score is 3. The device's critical function justifies High severity despite the lack of confirmed incidents.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator, model reference 99577-001957, part numbers V15-5-000586 and V15-7-000022. Eight units identified by the serial numbers provided in the recall notice are included in this recall.
Battery pins within these devices may become loose, potentially resulting in power loss. A defibrillator experiencing power loss may be unable to function properly if needed in an emergency.
The affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York. Consumers who believe they possess an affected device should verify the serial number against the official FDA recall notice for further guidance.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 8
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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