Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure
Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.
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: The recall involves a life-saving medical device that may fail to deliver therapy, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Physio-Control, Inc. is recalling 338 units of the LIFEPAK 15 Monitor, Automated External Defibrillator (AED). The recall involves 139 units in the United States and 199 units distributed internationally.
The firm identified a potential issue where the device may no longer be able to deliver defibrillation energy. This is caused by a potential failure of an internal component, specifically a Relay installed on the Therapy Printed Circuit Board Assembly (PCBA). The device is intended for use on adult and pediatric patients in manual mode, and for patients eight years of age and older in automated mode.
Affected units are distributed nationwide in the US and in numerous countries including Australia, Brazil, Canada, and the United Kingdom. Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
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 (20)
- SERIAL NUMBERS: 42738872
- 44554102
- 42701550
- 42702539
- 42730815
- 42800549
- 42803986
- 42862109
- 42884428
- 42944609
- 42989327
- 43022460
- 43040692
- 43048791
- 43066974
- 43116838
- 43116994
- 43119477
- 43132954
- 43133203
Distribution
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