Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

Recall date
August 26, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2842-2016
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.

Why it was recalled

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

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