Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.
FDA Recall Z-3204-2011 · Posted 2011-09-14
Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-03-17
Date Terminated2012-06-20
Product Quantity3791 units
Reason for Recall
An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
Firm Action
On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps.
Root Cause
Component design/selection
Distribution Pattern
Worldwide distribution including USA, Australia, Argentina, Italy, Morocco, South Korea, Belgium, Canada, Netherlands, Denmark, Japan, Hong Kong, Malaysia, Hungary, New Zealand, Sweden, Taiwan, Switzerland, Romania, Brazil, Slovakia, India, Colombia, UK, Ireland, Spain, Singapore, Martinique, Reunion, Venezuela, Iceland, Portugal, Turkey, Israel, Bahrain, Macau, Chile, Saudi Arabia, Latvia, China, Finland, Kazakhstan, Thailand, France, Poland, and Germany.
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.