Recall Z-2404-2011 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 | Jun 2, 2011 (initiated Apr 15, 2011) |
| 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. |
| Root cause | Other |
| Action | Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to |
| Quantity | 221 active devices |
| Distribution | Worldwide Distribution - USA including 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 |