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U.S. Department of Health and Human Services

Class 2 Device Recall Coherence Impression Therapist

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  Class 2 Device Recall Coherence Impression Therapist see related information
Date Initiated by Firm May 15, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on December 20, 2010
Recall Number Z-2096-2008
Recall Event ID 48439
510(K)Number K060226  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
Code Information Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1  Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
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		 Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.
Distribution Class II Recall - Product distribution information pending from firm.
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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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