Recall Z-0633-03 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
| Date | Mar 12, 2003 (initiated Jan 31, 2003) |
| Status | Terminated |
| Reason | The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned. |
| Root cause | Software design |
| Action | On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release. |
| Quantity | 12 units |
| Distribution | Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign dis |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |