Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections
Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.
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 the hazard involves a life-saving medical device that may lack required corrections, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 260 units of the HeartStart MRx Monitor/Defibrillators, including models M3535A, M3536A, and M3536M. The recall is being conducted because these specific devices may not have been included in prior field actions and therefore may not have received required corrections.
The affected devices were distributed worldwide, including in the United States, China, Republic of Korea, Netherlands, Norway, and United Kingdom. The devices are intended for use in the termination of ventricular tachycardia and ventricular fibrillation.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should contact Philips for instructions on how to receive the required corrections.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
- Manufacturer
- Philips North America, LLC
- Affected units
- 260
Distribution
Distributed nationwide across the United States.
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