Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.
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 and involves a structural defect in a life-support device that could induce ventricular fibrillation, meeting the criteria for a Severe rating.
Plain-English summary
Philips Healthcare Inc. is recalling approximately 66,150 units of the HeartStart MRx Monitor/Defibrillator. The affected model numbers are M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, and M3536M6. These devices are intended for use by qualified medical personnel trained in basic life support, advanced cardiac support, or defibrillation, and must be used by or on the order of a physician.
The recall is due to a risk that the device may deliver a non-synchronized cardioversion shock. This malfunction could result in the delivery of incorrect therapy, which may induce ventricular fibrillation in the patient.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Serial numbers for the affected devices range from US00100100 to US00567299. The serial numbers are printed on the primary label located on the back of the MRx in battery bay B. Users should contact Philips Healthcare Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 66,150
Distribution
Distributed nationwide across the United States.
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