LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.
What this means for you
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 medical device with potential power loss due to loose battery pins. No injuries or deaths have been reported, but the risk of malfunction in a life-saving device constitutes risk of harm to patients.
Plain-English summary
Physio-Control, Inc. is recalling certain LIFEPAK 15 defibrillators (REF: 99577-000055, Part Number V15-2-000061) due to a potential defect where battery pins may become loose within the device.
This defect could result in power issues. The recalled devices were distributed in Arizona, California, North Carolina, New Jersey, and New York.
For more information regarding this recall, contact Physio-Control, Inc.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
- Manufacturer
- Physio-Control, Inc.
- 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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Same hazard · loose battery pins
See all →- HighLIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
FDA (Devices) · 2023-11-22