Class 2 Device Recall 3D TOP Ceiling Stand

• Date Initiated by Firm: November 30, 2005
• Date Posted: December 31, 2005
• Recall Status: Terminated on July 19, 2006
• Recall Number: Z-0335-06
• Recall Event ID: 34191
• 510(K)Number: K802200
• Product Classification: Tube Mount, X-Ray, Diagnostic - Product Code IYB
• Product: 3D TOP Ceiling Stand. X-Ray System model number 8773673
• Code Information: Model number 8773673
• 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: screws on the rollers may become loose
• FDA Determined Cause: Other
• Action: The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.
• Quantity in Commerce: 460 units
• Distribution: The products were shipped to hospitals and medical facilities nationwide.
• 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.

• 510(K) Database: 510(K)s with Product Code = IYB