Z-1084-04

Linear accelerator workstation software suite

Name: Z-1084-04 Linear accelerator workstation software suite
Creator: Varian Medical Systems Inc
Published: 2004-05-27
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2004-05-27 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of Linear accelerator workstation software suite on 2004-05-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1084-04
Status: Terminated
Initiated: 2004-05-27
Posted: 2004-07-20
Terminated: 2004-12-20
Recalling firm: Varian Medical Systems, Inc.
Product: Linear accelerator workstation software suite
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: software
FDA 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 in commerce: 155 units
Distribution: units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including
Product codes and lots: 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

Product code IYE

K990085Class IIMillennium Mlc -120Varian Assoc., Inc. / cleared 1999-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)