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Recall Observatory FDA recall evidence

Device 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

Z-2746-2016

August 12, 2016

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 74915
Status
Terminated
Classification
Class II
Quantity
19 units (US) and 1975 units (OUS)
Official record key
device-enforcement:Z-2746-2016

Official wording

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.

Code information: Part Number/Catalog Number 1002.64A0

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.