FDA-Device2016-09-28Class II
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Philips Electronics North America Corporation
Hazard
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Sold states
Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.
Affected count
394 units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2842-2016Don't want to check this manually?
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