PlainRecalls
FDA Devices Moderate 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

Reported: September 14, 2016 Initiated: August 12, 2016 #Z-2746-2016

Product 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 for Recall

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.

Details

Units Affected
19 units (US) and 1975 units (OUS)
Distribution
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 19 units (US) and 1975 units (OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2746-2016.

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