Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure
Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, an FDA Class II recall involving a medical device that could delay life-saving therapy (defibrillation) is rated as Severe (4), as it poses a significant risk of harm even without reported injuries.
Plain-English summary
Philips Electronics North America Corporation is recalling five units of the HeartStart MRx Monitor/Defibrillator (Model No. M3535A and M3536A). 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.
If the device fails to charge, it could potentially cause therapy to be interrupted or delayed. The affected devices are intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.
The affected units were distributed worldwide to accounts in Ohio and North Carolina, as well as to Lebanon. Affected serial numbers include US00588464, US00588657, US00589878, US00591080, and US00593861. Users should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Defibrillator
- Affected units
- 5
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 (5)
- US00588464
- US00588657
- US00589878
- US00591080
- US00593861
Distribution
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