Recall Z-0455-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Oncology Systems
Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.
| Date | Nov 24, 2010 (initiated May 13, 2010) |
| Status | Terminated |
| Reason | Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record. |
| Root cause | Software design |
| Action | On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** |
| Quantity | 2417 units***12-20-12 AMENDED TO: 49 units*** |
| Distribution | Nationwide and Worldwide |
| FDA record | Open on fda.gov |