Recall Z-0304-2007 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190.
| Date | Dec 19, 2006 (initiated Sep 21, 2006) |
| Status | Terminated |
| Reason | Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient. |
| Root cause | Software design |
| Action | On September 21, 2006, the firm issued letters via certified mailing with return receipt to all its direct consignees, informing them of the affected product and providing instructions on the recall. |
| Quantity | 1689 units |
| Distribution | Nationwide. Defense Supply Center, VA or other Federal Government sales/distribution centers include: V.A. Medical Center, Atlanta, Dept. of Radiation Oncology, 1670 Clairmont Rd., Decatur, GA, 30030; V.A. Medical Center of Long Beach, Dept. of Rad. Oncology, 5901 E. 7th St., Long beach, CA 90745 |
| FDA record | Open on fda.gov |