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.
This recall has been terminated (originally issued January 11, 2012).
- Recall Initiated
- November 9, 2011
- Posted
- January 11, 2012
- Terminated
- April 15, 2013
- Recall Number
- Z-0459-2012
- Quantity
- 13 active devices
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.
Distribution
Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal
Lot / Code Info
Artiste MV system, part number 8139789 ONCOR Impression PLUS, part number 5857912
Root Cause
Component design/selection
Action Taken
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.