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.
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: 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
- 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: 00883873871683/ Serial number: 48839976
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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Same hazard · battery malfunction
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Similar recalls
- HighPhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss
FDA (Devices) · 2016-12-21
- HighLIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect
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- HighAC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On
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- SeverePhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition
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- SeverePhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits
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- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
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