Defibrillator battery pins may loosen, affecting power
Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.
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 medical device (defibrillator) where potential power loss could prevent life-saving treatment. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Physio-Control, Inc. has recalled the LIFEPAK 15 defibrillator (Model V15-7-000026, UDI: 00883873871669) due to a potential defect in which battery pins may become loose within the device.
Loose battery pins can result in power issues within the defibrillator, potentially affecting device function. Two units have been identified with serial numbers 48433670 and 48744028.
The affected devices were distributed nationwide to facilities in Arizona, California, North Carolina, New Jersey, and New York. This is a Class II recall issued by the FDA.
Healthcare facilities and users in possession of affected devices should verify the serial numbers on their equipment. Contact Physio-Control, Inc. for instructions regarding the recalled devices.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 2
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: 00883873871669/ Serial number: 48433670 and 48744028
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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