4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical Systems, Palo Alto, CA. The 4DITC is

FDA device recall Z-0691-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds dose for the control point at field edge, which should not be added according to the system specifications.

Action taken

Varian Medical Systems sent a Urgent Medical Device Notice dated December 22, 2011, to all affected customers via certified mail. The letter identified the product the problem and the action needed to be taken by the customer. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the recall. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Canadian account letters were sent by Fed Ex. International Customer Support Managers were sent letters for translation (when necessary) prior to sending to accounts. All of the information will be posted on the Varian web site and all appropriate personnel in the radiotherapy department should be advised of the content of this letter. A complete list of affected code numbers is included as well as contact information for Varian Oncology Help Desk. USA and Canada - 888-827-4265.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

4875 units

Distribution

Worldwide Distribution -- USA (nationwide)

Date initiated

2011-12-12

Date posted

2012-01-11

Date terminated

2012-07-26

Location

Palo Alto, CA

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