Recall Z-1397-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
| Date | Apr 2, 2008 (initiated Jan 11, 2008) |
| Status | Terminated |
| Reason | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Root cause | Software design |
| Action | This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it. |
| Quantity | 187 units |
| Distribution | Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |