Reported Sep 14, 2016 · Terminated
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- 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
- Lot codes and dates
- Part Number/Catalog Number 1002.64A0
- Amount recalled
- 19 units (US) and 1975 units (OUS)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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