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Terminated

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

FDA Recall Z-1205-06 · Posted 2006-07-06

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYB
Date Initiated2006-04-28
Date Terminated2008-09-30
Product Quantity466 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

The products were shipped nationwide to medical facilities.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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