Reported Mar 5, 2014 · Terminated

HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the…

Philips Medical Systems, 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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J 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
11327-0019-P
11315-0023-P
11315-0027-P
11315-0031-P
11315-0032-P
11315-0033-P
11315-0036-P
11315-0109-P
11315-0214-P
11315-0219-P
11315-0391-P
11322-0084-P
11322-0088-P
11327-0043-P
11327-0044-P
Or within the following range11335-xxxx-P to 13214-xxxx-P
Amount recalled: 43,792 batteries

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

Nationwide

Why it was recalled

Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Philips Medical Systems, Inc.

31 in total.

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