Z-3100-2011

Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc...

Name: Z-3100-2011 Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-06-27
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-06-27 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan... on 2011-06-27. The reason FDA records is "In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will...". 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-3100-2011
Status: Terminated
Initiated: 2011-06-27
Posted: 2011-08-30
Terminated: 2013-12-05
Recalling firm: Varian Medical Systems, Inc.
Product: Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different than planned.
Root cause tag: software
FDA root cause: Software design
Action: Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 27, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that Varian Service will contact customers to arrange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification, contact your local Varian Customer Support District or Regional Manager. The letter also provides Varian Oncology Help desk contact information 1-888-827-4265 for USA and Canada and +41417498844 for Europe.
Quantity in commerce: 645
Distribution: Worldwide Distribution - USA (nationwide)
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Product code IYE

K081036Class II4D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Varian Medical Systems, Inc. / cleared 2008-05-09

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)