Philips Healthcare Inc.: Medical Device Recall in 2012 - (Recall #: Z-1986-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 20, 2012

Date Posted: July 18, 2012

Recall Number: Z-1986-2012

Event ID: 62342

Reason for Recall:

Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG

Status: Terminated

Product Quantity: 35 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA

Voluntary or Mandated:

Voluntary: Firm initiated