Z-1385-2012

VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is...

Name: Z-1385-2012 VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is...
Creator: Varian Medical Systems, Inc.
Published: 2012-01-25
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-01-25 / Terminated / root cause: labeling and UDI

FDA source

Varian Medical Systems, Inc. began a recall of VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning... on 2012-01-25. The reason FDA records is "Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1385-2012
Status: Terminated
Initiated: 2012-01-25
Posted: 2012-04-10
Terminated: 2012-11-07
Recalling firm: Varian Medical Systems, Inc.
Product: VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
Product code: KXK Source, Brachytherapy, Radionuclide
Reason for recall: Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.
Quantity in commerce: 1377 units
Distribution: Worldwide Distribution
Product codes and lots: device is not coded

Product code KXK

K030534Class IIVariseed 7.1Varian Medical Systems / cleared 2003-05-21

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)