Class 3 Device Recall Arcadis Varic

• Date Initiated by Firm: August 01, 2005
• Date Posted: November 02, 2005
• Recall Status: Terminated on July 19, 2006
• Recall Number: Z-0118-06
• Recall Event ID: 33082
• 510(K)Number: K042793
• Product Classification: System, X-Ray, Mobile - Product Code IZL
• Product: Arcadis Varic Mobile X-Ray System
• Code Information: Model number 8080017
• 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 may become loose and fall into the OR field during surgery.
• FDA Determined Cause: Other
• Action: The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
• Quantity in Commerce: 24 units
• Distribution: The products were shipped nationwide to a distributor, a physician, and 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 = IZL