—#45995

Product

3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

FDA product code: IYB — Tube Mount, X-Ray, Diagnostic
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Model numbers 0923/G0923, 1022, 1080, 1212687, 1371970, 1372325, 1654250, 1576164, 8186751, 7388002, 7389489, 1738509, 1738517, 1738525, 7276504, 7276512, 7276520, 7276553, 7465008, 7486822, and 8185530.

Why it was recalled

Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The products were shipped nationwide to medical facilities.

Timeline

Recall initiated: 2006-04-28
Posted by FDA: 2006-07-06
Terminated: 2008-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.