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Recall Observatory FDA recall evidence

Device 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.

Z-0963-2015

November 19, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69747
Status
Terminated
Classification
Class II
Quantity
74,499 devices
Official record key
device-enforcement:Z-0963-2015

Official wording

Reason: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

Code information: Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.