Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure
Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.
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 agency classified this as a Class II recall. The device is a critical life-support medical device, and a failure to charge poses a significant risk of harm to patients requiring defibrillation, fitting the 'Severe' criteria for significant injury risk or structural defect in a high-risk product.
Plain-English summary
Philips Electronics North America Corporation is recalling 17 units of the HeartStart MRx Monitor/Defibrillator. The recall is due to a defect in the therapy printed circuit board, which may have been loaded with an incorrect electronic component. This defect could cause the device to fail to charge.
The affected devices were distributed worldwide, including in the United States (Ohio, California, and North Carolina) and internationally to China, Iraq, Japan, and Korea. The HeartStart MRx is intended for use by qualified medical personnel trained in basic life support, advanced cardiac support, or defibrillation to terminate ventricular tachycardia and ventricular fibrillation.
Users should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life…
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 17
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 (17)
- US00586611
- US00589878
- US00594232
- US00588464
- US00591080
- US00594779
- US00588657
- US00592182
- US00594913
- US00589391
- US00593861
- US00595298
- US00589472
- US00594092
- US00595443
- US00589851
- US00594168
Distribution
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