FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: Linear accelerator workstation software suite
- Recall number
- Z-1084-04
- Recalling firm
- Varian Medical Systems Inc
- Product
- Linear accelerator workstation software suite
- Status
- Terminated
- Initiated
- 2004-05-27
- Posted
- 2004-07-20
- Terminated
- 2004-12-20
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- K990085
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28