Philips HeartStart MRx Monitor/Defibrillator Recall for Handle Separation
Philips is recalling 394 HeartStart MRx Monitor/Defibrillators because the handle can separate from the housing due to broken mounts.
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 involves a medical device with a structural defect (handle separation) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is recalling 394 units of the HeartStart MRx Monitor/Defibrillator, Models M3535A and M3536A. The recall is due to a defect where the handle can separate from the MRx housing caused by breakage of mounts on the rear case.
The affected units were distributed worldwide, including in the United States, Canada, Australia, France, Germany, India, Japan, the Netherlands, South Africa, Spain, Sweden, Thailand, and the United Kingdom. The recall specifically includes MRx units that have the Old Cap Plate and were shipped before 2010.
Consumers and healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should stop using the affected devices and contact Philips for further instructions on repair or replacement.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Defibrillator
- Affected units
- 394
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)
- shipped before 2010.
Distribution
Distributed nationwide across the United States.
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