—#105696

Product

ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226, K103505
Affected lot / code info: Artiste MV system, part number 8139789 ONCOR Impression PLUS, part number 5857912

Why it was recalled

Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

Root cause (FDA determination)

Component design/selection

Action the firm took

Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal

Timeline

Recall initiated: 2011-11-09
Posted by FDA: 2012-01-11
Terminated: 2013-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.