Class 2 Device Recall 3DI/III Ceiling Stand

• Date Initiated by Firm: April 28, 2006
• Date Posted: July 06, 2006
• Recall Status: Terminated on September 30, 2008
• Recall Number: Z-1205-06
• Recall Event ID: 35395
• Product Classification: Tube Mount, X-Ray, Diagnostic - Product Code IYB
• Product: 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
• Code Information: 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.
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 466 units
• Distribution: The products were shipped nationwide to medical facilities.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.