Reported Jul 18, 2012 · Terminated

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the…

Philips Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810

Is this the product you have?

  • 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
Lot codes and dates
  • 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
Amount recalled
35 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 14, 2013 · Data as of Sep 19, 5:24 PM UTC

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