Varian Medical Systems Inc Linear accelerator workstation software suite Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Linear accelerator workstation software suite
Brand
Varian Medical Systems Inc
Lot Codes / Batch Numbers
MLC Workstation v 6.3 and 6.4
Products Sold
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
Varian Medical Systems Inc is recalling Linear accelerator workstation software suite due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026