Class 2 Device Recall Impression Therapist 3rd party V&R

• Date Initiated by Firm: November 06, 2007
• Date Posted: October 16, 2008
• Recall Status: Terminated on December 18, 2010
• Recall Number: Z-0094-2009
• Recall Event ID: 48432
• 510(K)Number: K060226
• Product Classification: Medical Linear Accelerator - Product Code IYE
• Product: Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345429 Medical charged-particle radiation therapy system.
• Code Information: Serial numbers associated with RTT2.0 and RTT2.1
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 4040 Nelson Ave; Concord CA 94520-1200
• For Additional Information Contact: 925-246-8407
• Manufacturer Reason for Recall: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
• FDA Determined Cause: Software design
• Action: Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.
• Quantity in Commerce: 1 unit
• Distribution: Worldwide Distribution
• 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 = IYE