Recall Z-1652-2014 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
| Date | May 23, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models. |
| Root cause | Labeling design |
| Action | Siemen sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Elekta representative. |
| Quantity | 9 |
| Distribution | US Nationwide Distribution in the states of AL, ME, PA, IL, and CA. |
| 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 |