Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues
Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (defibrillator) where therapy interruption could occur, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 75,693 units of the HeartStart MRx monitor/defibrillator. The affected models include M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, and M3536M6. These devices are used by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.
The recall was initiated because the devices could reboot at an indeterminate time. This unexpected reboot could potentially cause therapy to be interrupted or delayed. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected units were distributed worldwide, including in the United States and numerous international countries. Users should check their device model and serial numbers against the provided ranges to determine if their unit is affected. If a device is affected, users should contact Philips Medical Systems for further instructions on corrective actions.
The recalled product
- Product
- HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 75,693
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)
- US00554177
Distribution
Distributed nationwide across the United States.
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