Z-2766-2011

TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA

Name: Z-2766-2011 TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-05-19
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-05-19 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision... on 2011-05-19. The reason FDA records is "Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2766-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-07-08
Terminated: 2012-03-13
Recalling firm: Varian Medical Systems, Inc.
Product: TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
Root cause tag: design
FDA root cause: Device Design
Action: Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.
Quantity in commerce: 77
Distribution: Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product codes and lots: Model numbers: H14, H19, H27, H29. Serial numbers: H191001 H191012 H191022 H191032 H191043 H191054 H191066 H191083 H191002 H191013 H191023 H191033 H191044 H191055 H191067 H191085 H191003 H191014 H191024 H191034 H191045 H191056 H191070 H191086 H191005 H191015 H191025 H191035 H191046 H191057 H191071 H191089 H191006 H191016 H191026 H191036 H191047 H191058 H191072 H191090 H191007 H191017 H191027 H191037 H191048 H191059 H191076 H191091 H191008 H191018 H191028 H191038 H191049 H191060 H191077 H191092 H191009 H191019 H191029 H191039 H191051 H191061 H191078 H191010 H191020 H191030 H191041 H191052 H191063 H191079 H191011 H191021 H191031 H191042 H191053 H191064 H191080

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)