Linear accelerator workstation software suite
This recall has been terminated (originally issued July 20, 2004).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- May 27, 2004
- Posted
- July 20, 2004
- Terminated
- December 20, 2004
- Recall Number
- Z-1084-04
- Quantity
- 155 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including
Lot / Code Info
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 Taken
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.