Recall Z-1493-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are
| Date | May 7, 2012 (initiated Apr 3, 2012) |
| Status | Terminated |
| Reason | Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2). |
| Root cause | Labeling design |
| Action | Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow. |
| Distribution | Worldwide Distribution - USA including the states of CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV |
| FDA record | Open on fda.gov |