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U.S. Department of Health and Human Services

Class 2 Device Recall 4D Intergrated Treatment Console

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 Class 2 Device Recall 4D Intergrated Treatment Consolesee related information
Date Initiated by FirmFebruary 28, 2011
Date PostedApril 29, 2011
Recall Status1 Terminated 3 on March 30, 2012
Recall NumberZ-2119-2011
Recall Event ID 58230
510(K)NumberK091132 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductThe 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.
Code Information Affected Serial Numbers:  H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information ContactPatricia Erwin, RAC
650-424-5731
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionVarian 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
Quantity in Commerce17
DistributionClass 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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