Fixture 1002.65A0 (2016-07-20)

Starting date:

July 20, 2016

Posting date:

August 19, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59850

• Reason
• Affected products

Affected products

A. Fixture 1002.65A0

Reason

The fixture (1002.65a0) is designed as a connecting element for the support and positioning of the patient's head on a Maquet or 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 rests and horseshoe head rests with a central square mount. As part of post market surveillance, cases have been reported to Maquet GMBH which showed the welded joint between square mount and the first fixable swivel joint broke. This joint must bear the highest loads of all welded joints due to the cantilever. It is likely that the breakage had been caused by a poor welding joint, in addition to rough handling and multiple overload by the user respectively. If the weld seam breaks during a procedure, a serious injury cannot be ruled out.

Affected products