Recall Z-1212-2017 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
| Date | Jan 25, 2017 |
| Status | Terminated |
| Reason | Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension. |
| Root cause | Device Design |
| Action | Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 7, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Siemens will contact customers to arrange a date for the installation of the software update. |
| Quantity | 194 systems |
| Distribution | United States 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 |