Recall Z-2746-2016— Maquet Cardiovascular Us Sales, Llc
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2016-08-12, terminated 2017-05-04. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-12
- Terminated
- 2017-05-04
- Firm location
- Wayne, NJ, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.