Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by Varian Medical System, Palo Alto, CA. Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall Z-0181-2012 · Posted 2011-11-09
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-09-09
Date Terminated2012-07-24
Product Quantity5823 devices
Reason for Recall
Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
Firm Action
The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated September 9, 2011 to all affected customers via Federal Express with attached instructions. The letter provides the description of problem; references, details, recommended user actions, and varian actions.
***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
In addition, the letter also states "THIS LETTER IS NOT A SUBSTITUTE FOR THE CAREFUL REVIEW OF ALL USER DOCUMENTATION ASSOCIATED WITH YOUR PARTICULAR EQUIPMENT AND SOFTWARE."
If you have any questions, contact Varian Oncology Help Desk at USA and Canada: 1.888.VARIANS (888.827.4265); Europe +41 41 749 8844 and/or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution.
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.