Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Failure to Deliver Therapy
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 (Critical) according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Philips North America, LLC is recalling HeartStart MRx Monitor/Defibrillators, including models M3535A, M3536A, and various M3536M series units. The recall affects 97,794 units distributed worldwide, including 47,362 units in the United States and 50,429 units in other countries.
The recall is due to a potential defect where the device may exhibit abnormal behavior when operating using a single battery as the sole source of power. In such cases, the device may fail to deliver therapy or monitoring. This is classified as an FDA Class I recall, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death.
Healthcare facilities and users should stop using the affected devices as the sole source of power with a single battery and contact Philips for further instructions on replacement or repair. Specific serial number ranges for affected models are available in the official recall documentation.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
- Manufacturer
- Philips North America, LLC
Distribution
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