Z-1314-04

medical device and software systems

Name: Z-1314-04 medical device and software systems
Creator: Varian Medical Systems Inc
Published: 2004-06-24
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2004-06-24 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of medical device and software systems on 2004-06-24. The reason FDA records is "a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a...". 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-1314-04
Status: Terminated
Initiated: 2004-06-24
Posted: 2004-08-07
Terminated: 2004-12-23
Recalling firm: Varian Medical Systems, Inc.
Product: medical device and software systems
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
Root cause tag: software
FDA root cause: Other
Action: Notification letter to consignees sent 06/14/2004.
Quantity in commerce: 28 units
Distribution: produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
Product codes and lots: Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)

Product code MUJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)