Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage
Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.
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, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).
Plain-English summary
Philips Medical Systems, Inc. is recalling 39,128 units of the HeartStart MRx Monitor/Defibrillator. The affected models are M3535A, M3536A, M3536J, and M3536MC. The device is intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.
The recall is due to a potential defect where a component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD). This damage can disrupt ECG and SpO2 functionality, leading to an inability to perform. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the United States and internationally to numerous countries including Canada, Australia, and various nations in Europe, Asia, and the Americas. Users should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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 i
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 39,128
Distribution
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