Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits
Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a critical life-saving device (defibrillator) that may fail to deliver a shock, posing a significant risk of serious injury or death.
Plain-English summary
Physio-Control, Inc. is recalling 705 units of the LIFEPAK 15 Monitor/Defibrillator service kits. The recall is due to a defect where oxidation forms over time within the "Shock" button on the keypad. This oxidation may prevent the monitor/defibrillator from delivering a shock when the button is pressed.
The affected units were distributed worldwide, including in all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous foreign countries. The recall is classified as FDA Class II. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities and users should check their inventory for the affected serial numbers. If a unit is affected, it should be removed from service and returned to Physio-Control for repair or replacement according to the company's instructions.
The recalled product
- Product
- LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 705
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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