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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