Recall Z-1314-04 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Inc
medical device and software systems
| Date | Aug 7, 2004 (initiated Jun 24, 2004) |
| Status | Terminated |
| Reason | a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session. |
| Root cause | Other |
| Action | Notification letter to consignees sent 06/14/2004. |
| Quantity | 28 units |
| Distribution | produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.