Philips HeartStart MRx Defibrillators Recalled for Wear Risk
Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.
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 injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling 58,466 units of the HeartStart MRx Monitor/Defibrillator. The affected model numbers are M3535A, M3536A, M3536J, M3536M, and M3536MC. These devices were distributed worldwide, including nationwide in the United States and in numerous other countries.
The recall was initiated because the therapy connection on the defibrillator monitor could experience accelerated wear. This defect creates a risk for patients and/or caregivers. The agency has classified this recall as Class II.
Affected serial number ranges are: M3535A (USD0100104 - USD0572207), M3536A (USD0100902 - USD0543688), M3536J (USD0209838 - USD0332675), M3536M (USD0500002 - USD0500009), and M3536MC (USD0500002 - USD0500028). Users should check their device serial numbers against these ranges and contact the recalling firm for instructions.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 58,466
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 (4)
- M3536A Serial Numbers: USD0100902 - USD0543688
- M3536J Serial Numbers USD0209838 - USD0332675
- M3536M Serial Numbers: USD0500002 - USD0500009
- M3536MC Serial Nukmbers: USD0500002 - USD0500028
Distribution
Distributed nationwide across the United States.
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