High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
FDA Recall Z-3052-2011 · Posted 2011-08-22
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-06-06
Date Terminated2011-12-23
Product Quantity173***12-20-12 AMENDED TO: 106 units***
Reason for Recall
When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.
Firm Action
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
***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.***
The letter describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC.
Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.
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.
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