4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Varian Medical Systems, Palo Alto, CA

FDA device recall Z-3194-2011 · posted 2011-09-14 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system.

Action taken

Urgent Medical Device Correction/Field Safety Notification letters were sent to all US consignees by Certified Mail on July 21, 2011., as well as Varian Sales, Marketing and Service Organizations. Varian International Customer Support managers will notify international customers by appropriate methods. The letter informed customers of the issue and the corrective action steps. Letters request that all appropriate personnel working in the radiotherapy department be notified of the contents of the letter. A new release version is being created to correct the issue. All sites will be notified when it is available. Questions or concerns should be directed to 1-888-827-4265. Contact information for international customers is also provided as well as a list of all affected serial numbers.

Root cause

Pending

Status

Terminated

Product code

IYE

Quantity affected

1125

Distribution

Worldwide Distribution -- USA, China, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guadeloupe, Ireland, Italy, Latvia, Lithuania, Martinique, Netherlands, Po

Date initiated

2011-07-21

Date posted

2011-09-14

Date terminated

2013-08-01

Location

Palo Alto, CA

Related 510(k) clearances