FDAFDA · Alimentos y medicamentos·N.º oficial 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
Publicado el 14 de septiembre de 2016 · Inicio del retiro: 12 de agosto de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Maquet Cardiovascular Us Sales, Llc
- Distribuidor
- Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
- Lote
- Part Number/Catalog Number 1002.64A0
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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