Maquet Cardiovascular Us Sales, Llc recalls The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests…

Recall date

August 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2746-2016

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI

Why it was recalled

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.

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

What was recalled

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