Z-0106-2011

Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian...

Name: Z-0106-2011 Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian...
Creator: Varian Medical Systems Oncology Systems
Published: 2010-05-24
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-05-24 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA on 2010-05-24. The reason FDA records is "Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position...". 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-0106-2011
Status: Terminated
Initiated: 2010-05-24
Posted: 2010-10-20
Terminated: 2011-07-20
Recalling firm: Varian Medical Systems, Inc.
Product: Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision.
Root cause tag: software
FDA root cause: Software design
Action: Varian Medical Systems issued an Urgent Medical Device Correction letter date dated May 24, 2010 to users identifying the affected device, the issue prompting the correction, and the actions to be taken by the user. Customers were asked to set couch tolerance values to small numbers, and for radiosurgical treatment tolerance values to be set to zero. A Varian representative will contact customers to schedule installation of a software version correcting the issue. US Customers can contact Varian at 1-888-827-4265,. European customers can contact Varian at +41 41 749 8844.
Distribution: Worldwide Distribution: Two consignees, one in the US and one in Switzerland.
Product codes and lots: H191001, H191003

Product code IYE

K092871Class IITrilogy MxVarian Medical Systems, Inc. / cleared 2009-11-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)