Linear accelerator workstation software suite
FDA device recall Z-1084-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- 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
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 155 units
- Distribution
- units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including
- Date initiated
- 2004-05-27
- Date posted
- 2004-07-20
- Date terminated
- 2004-12-20
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM MLC -120 (K990085) | Varian Assoc., Inc. | 1999-02-08 |