FDAFDA · Food and drugs·Recall number Z-1986-2012
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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 July 18, 2012 · Recall initiated: June 20, 2012
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
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
- Lot
- Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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