Z-0633-03

VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction...

Name: Z-0633-03 VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction...
Creator: Varian Medical Systems Inc
Published: 2003-01-31
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2003-01-31 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x on 2003-01-31. The reason FDA records is "The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned". 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-0633-03
Status: Terminated
Initiated: 2003-01-31
Posted: 2003-03-12
Terminated: 2003-09-17
Recalling firm: Varian Medical Systems, Inc.
Product: VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
Root cause tag: software
FDA root cause: Software design
Action: On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.
Quantity in commerce: 12 units
Distribution: Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
Product codes and lots: Affected Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045

Product code IYE

K001643Class IIVaris 1.4GVarian Medical Systems, Inc. / cleared 2000-06-23

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)