Philips HeartStart MRx Recall Due to AC Power Module Failure Risk
Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 medical device that may fail to deliver life-saving shocks or pacing, which constitutes a significant injury risk.
Plain-English summary
Philips North America, LLC is recalling approximately 97,794 units of HeartStart MRx devices that are in use with the M3539A AC Power Module. The affected device models include M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9. These devices were distributed nationwide and worldwide.
The recall is being issued because the AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the device may lose all power and fail to operate. This can result in an interruption of monitoring and a failure or delay in the delivery of a shock or pacing. Additionally, a faulty AC power module may fail to charge the battery.
Consumers and healthcare facilities should check their device serial numbers against the list provided by the FDA or Philips to determine if their unit is affected. If a device is affected, users should contact Philips for instructions on how to proceed, which may involve replacing the power module or the device itself.
The recalled product
- Product
- Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 97,794
Distribution
Distributed nationwide across the United States.
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