LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.
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 a Class II medical device recall. Battery pins becoming loose and causing power loss poses a direct risk to device function in a life-critical application. No illnesses or injuries have been reported to date, meeting the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (REF: 99577-000046, Part Number V15-2-000051) due to the potential for battery pins to become loose within the device.
A loose battery connection can result in power loss, preventing the defibrillator from functioning when needed. This poses a risk during cardiac emergencies when the device is relied upon for life-saving treatment.
The recalled defibrillator has been distributed nationwide in the following states: Arizona, California, North Carolina, New Jersey, and New York. The affected unit identified in this recall carries serial number 38370274.
If you have this device, stop using it immediately and contact Physio-Control, Inc. to arrange inspection, repair, or replacement. Healthcare facilities should verify the serial numbers of their LIFEPAK 15 units and ensure alternative defibrillation systems are available.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- 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: 00883873988022/ Serial number: 38370274
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
Same manufacturer · Physio-Control, Inc.
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