Class 2 Device Recall 3D Ceiling Suspension

• Date Initiated by Firm: April 15, 2003
• Date Posted: July 10, 2003
• Recall Status: Terminated on April 11, 2005
• Recall Number: Z-0987-03
• Recall Event ID: 26458
• 510(K)Number: K790765 K803130
• Product Classification: System, X-Ray, Tomographic - Product Code IZF
• Product: 3D Ceiling Suspension
• Code Information: all serial numbers
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Parkway; Malvern PA 19355
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: the back up safety catch may not function properly
• FDA Determined Cause: Other
• Action: Letters dated 4/15/03 and 4/23/03 were issued to the accounts along with instructions on how to fix the problem.
• Quantity in Commerce: 3504 units
• Distribution: The product was 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.

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