FDAFDA · Food and drugs·Recall number Z-0963-2015
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.
Published January 21, 2015 · Recall initiated: November 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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