Recall Z-1084-04 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Linear accelerator workstation software suite
| Date | Jul 20, 2004 (initiated May 27, 2004) |
| Status | Terminated |
| Reason | An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1 |
| Root cause | Software design |
| Action | Varian will notify customers via phone beginning 5/27/2004 and distribute a product notification letters June 3, 2004, notifying them of the anomaly and corrective action, and finally, the anomaly will be corrected by a future release of software. |
| Quantity | 155 units |
| Distribution | units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990085 | MILLENNIUM MLC -120 Varian Assoc., Inc., Feb 8, 1999 |