Z-0213-2008

Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian...

Name: Z-0213-2008 Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian...
Creator: Varian Medical Systems Inc
Published: 2007-06-25
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2007-06-25 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems on 2007-06-25. The reason FDA records is "Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning...". 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-0213-2008
Status: Terminated
Initiated: 2007-06-25
Posted: 2007-11-08
Terminated: 2008-02-04
Recalling firm: Varian Medical Systems, Inc.
Product: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
Product code: KPQ System, Simulation, Radiation Therapy
Reason for recall: Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---
Product codes and lots: Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973

Product code KPQ

K851653Class IIVarian/ximatron 5 Carbon-Fiber Couch TopVarian Assoc., Inc. / cleared 1985-05-23

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)