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Philips Medical Systems, Inc. recalls HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5
Recalled January 21, 2015 · FDA recall Z-0963-2015 · Philips Medical Systems
Hazard
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. · FDA Class II
Units
74,499 devices
Sold at
Worldwide Distribution - US Nationwide
Description
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Product
HeartStart MRx Monitor/Defibrillator; Model. Numbers: 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 qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →