—#71422

Product

Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. 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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: 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.

Why it was recalled

Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Class II Recall - Product distribution information pending from firm.

Timeline

Recall initiated: 2008-05-15
Posted by FDA: 2008-09-17
Terminated: 2010-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71422. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.