—#115590

Product

SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121295
Affected lot / code info: All codes/units of ARTISTE model.

Why it was recalled

Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

Root cause (FDA determination)

Software design

Action the firm took

The firm issued "Urgent Medical Device Correction" letters via mail to all its direct consignees, informing them of the affected product issue and providing instructions on the recall. The firm stated that the release of this UI TH005/13/S to distribute the Customer Safety Advisory Notice began on January 17, 2013.

Recalling firm

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

Distribution

Distribution pattern: 5 devices, all located outside of the United States in Germany.

Timeline

Recall initiated: 2013-01-17
Posted by FDA: 2013-03-05
Terminated: 2013-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.