Z-0176-03

BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into...

Name: Z-0176-03 BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into...
Creator: Varian Brachytherary Virginia
Published: 2003-10-31
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2003-10-31 / Terminated / root cause: software

FDA source

Varian Brachytherary Virginia began a recall of BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision... on 2003-10-31. The reason FDA records is "The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient". 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-0176-03
Status: Terminated
Initiated: 2003-10-31
Posted: 2003-12-03
Terminated: 2003-12-15
Recalling firm: Varian Medical Systems, Inc.
Product: BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
Product code: LNX
Reason for recall: The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.
Quantity in commerce: 29 sets
Distribution: Software was distributed to end users nationwide and internationally.
Product codes and lots: Versions 6.1 and 6.5

Product code LNX

K992762Class IIBrachyvision 6.0Varian Assoc., Inc. / cleared 2000-03-09

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)