FDA-Device2016-09-14Class II
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
Maquet Cardiovascular Us Sales, Llc
Hazard
Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
Sold states
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Affected count
19 units (US) and 1975 units (OUS)
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2016Don't want to check this manually?
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