Class 2 Device Recall Arcadis Varic

• Date Initiated by Firm: December 12, 2005
• Date Posted: January 25, 2006
• Recall Status: Terminated on September 04, 2008
• Recall Number: Z-0439-06
• Recall Event ID: 34397
• 510(K)Number: K040066
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: Arcadis Varic Mobile X-ray System
• Code Information: model number 8080017 All units
• 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: patient information can be stored in another patient's file.
• FDA Determined Cause: Other
• Action: The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue.
• Quantity in Commerce: 179 units
• Distribution: The product was shipped to 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 = JAK