Recall Z-0355-06 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.
| Date | Jan 6, 2006 (initiated Jan 8, 2003) |
| Status | Terminated |
| Reason | Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas. |
| Root cause | Other |
| Action | On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. |
| Quantity | 125 units |
| Distribution | 28 units shipped within the US, 97 shipped internationally, to countries including Japan, India, Taiwan, Hungary, Italy, France, Colombia, Germany, Austria, CAnada, Croatia, Poland, Croatia, Brazil, Turkey, Greece, Egypt, China, South Korea, Malaysia, Herzogovina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |