Recall Z-0393-06 ยท IWB System, Radiation Therapy, Radionuclide
Varian Medical Systems Inc
Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Product is distrib
| Date | Jan 18, 2006 (initiated Nov 23, 2005) |
| Status | Terminated |
| Reason | The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment. |
| Root cause | Other |
| Action | On 11/23/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. |
| Distribution | Worldwide to 219 accounts. U.S. States: AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV. 118 accounts Foreign consignees include Netherlands, Thailand, Taiwan, R.O.C., Sweden, Spain, South Korea, South Af |
| FDA record | Open on fda.gov |