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.
FDA Recall Z-2766-2011 · Posted 2011-07-08
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-19
Date Terminated2012-03-13
Product Quantity77
Reason for Recall
Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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