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Terminated

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.

FDA Recall Z-3100-2011 · Posted 2011-08-30

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-06-27
Date Terminated2013-12-05
Product Quantity645

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0810364D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)Varian Medical Systems, Inc. · 2008-05-09

Official Source

View FDA Recall →

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

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