Z-2119-2011

The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File...

Name: Z-2119-2011 The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-02-28
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-02-28 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and... on 2011-02-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2119-2011
Status: Terminated
Initiated: 2011-02-28
Posted: 2011-04-29
Terminated: 2012-03-30
Recalling firm: Varian Medical Systems, Inc.
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 17
Distribution: 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.
Product codes and lots: Affected Serial Numbers: H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891

Product code IYE

K091132Class II4D Integrated Treatment ConsoleVarian Medical Systems / cleared 2009-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)