Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall Z-0821-2011 · Posted 2010-12-28
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Recalling FirmVarian Medical Systems Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-07-20
Date Terminated2011-07-18
Reason for Recall
The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.
Firm Action
Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display "RapidArc" or "VMAT" under Treatment Type during dose delivery, discontinue use of the device and call Varian service.
Varian Service Help Desk can be contacted at 1-888-827-4265.
Root Cause
Software design
Distribution Pattern
Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.
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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