Recall Z-0857-2009 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
| Date | Jan 14, 2009 (initiated Oct 23, 2008) |
| Status | Terminated |
| Reason | Under certain conditions, the flat panel may move unexpectedly and collide with the patient. |
| Root cause | Labeling design |
| Action | The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediate |
| Quantity | 31 consignees have the configuration noted above. |
| Distribution | Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada. |
| 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 |