FDA Enforcement
Class II
Terminated
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
Recall: Z-2746-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2746-2016
- Event ID
- 74915
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 14, 2016
- Initiation Date
- August 12, 2016
- Classification Date
- September 7, 2016
- Termination Date
- May 4, 2017
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States
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
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 Info
Part Number/Catalog Number 1002.64A0
Distribution
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Quantity
19 units (US) and 1975 units (OUS)