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Terminated

The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

FDA Recall Z-2119-2011 · Posted 2011-04-29

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-02-28
Date Terminated2012-03-30
Product Quantity17

Reason for Recall

A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.

Firm Action

Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers. Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com. This design fix in 4DITC v10.1 or later will be provided to all affected sites. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager. USA and Canada - 1-888-VARIANS (888-827-4265) Europe - + 41 41 749 8844

Root Cause

Software design

Distribution Pattern

Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0911324D INTEGRATED TREATMENT CONSOLEVarian Medical Systems · 2009-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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