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Maquet Cardiovascular Us Sales, Llc recalls The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests
Recalled September 14, 2016 · FDA recall Z-2746-2016 · Maquet Cardiovascular Us Sales
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. · FDA Class II
Units
19 units (US) and 1975 units (OUS)
Sold at
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Description
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.
Product
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
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →