Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.
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 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 states that one report involved the death of a patient, which meets the rubric criterion for a Critical (5) severity score.
Plain-English summary
Philips North America, LLC is recalling HeartStart MRx Monitor/Defibrillators with specific model numbers (M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9). The recall involves 97,788 units distributed domestically in the United States and internationally.
The recall was initiated after Philips received reports that the devices suffered internal damage and were unable to deliver therapy after being dropped or subjected to severe mechanical shock. In these instances, the devices did not show visible external damage, and the Ready for Use (RFU) indicator did not immediately indicate a problem. One of the reports involved the death of a patient who could not be resuscitated.
All units are affected by this recall. Users should contact Philips for instructions on how to proceed with the recall.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 97,788
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 (1)
- All units are affected by this recall
Distribution
Distributed nationwide across the United States.
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