FDA Recall Terminated

4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: 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.

Recall: Z-0891-2011 · Initiated October 16, 2009

Recall

Recall Number: Z-0891-2011
Event Number: 54146
Firm: Varian Medical Systems Oncology Systems
FEI Number: 2916710
Product Code: IYE
Status: Terminated
Root Cause: Device Design
Initiated: October 16, 2009
Posted: January 10, 2011
Terminated: July 20, 2011
Address: 911 Hansen Way, Palo Alto, CA, 94304-1028

Description

Reason

Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.

Action

The firm, Varian Medical Systems, sent a Product Notification Letter/Field Safety Letter entitled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2009, to all affected customers. The letter described the product, problem, actions to be taken by the customers and Varian. The customers were instructed to use caution when creating CBCT imaging field and limit use of the 'select all' button when acquiring treatment parameters; review departmental policies and procedures regarding the acquisition of any gantry angle at the 4D ITC, and advise the appropriate personnel of this letter. The firm, Varian, recommended that only vertical, longitudinal and lateral couch parameters are acquired when creating a CBCT field at the 4D ITC; notified all affected customers of this document, and will correct this issue in a future release of the 4D ITC software. If owners of $D ITC, version 8.0.12 and higher, have any questions regarding this product notification letter, please contact Varian Medical Systems Help Desk at 1-888-VARIANS (888-827-4265) for USA and Canada, +41 41 749 8844 or [email protected] for Europe; Emails for North American: [email protected]; Australia/New Zealand: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected] and Latin American: [email protected], and Internets for Oncology Systems- www.myvarian.com and Varian Medical Systems- www.varian.com.

Distribution

Worldwide distribution: USA and countries including: Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia.

Quantity

3629