FDAFDA · Food and drugs·Recall number Z-2746-2016
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
Published September 14, 2016 · Recall initiated: August 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
- Lot
- Part Number/Catalog Number 1002.64A0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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