Date Initiated by Firm | May 15, 2008 |
Date Posted | September 17, 2008 |
Recall Status1 |
Terminated 3 on December 20, 2010 |
Recall Number | Z-2099-2008 |
Recall Event ID |
48439 |
510(K)Number | K060226 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345429. 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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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