Recall Z-1422-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc., Concord, CA
Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solu
| Date | Feb 24, 2011 (initiated Dec 3, 2010) |
| Status | Terminated |
| Reason | The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient. |
| Root cause | Other |
| Action | The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407. |
| Quantity | 20 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |