Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision devi

FDA device recall Z-0516-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.

Action taken

The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated December 1, 2011 to all affected sites via Certified mail, return receipt. Canadian accounts were sent by Fed Ex and internationally to Varian International Customer Support Managers for translation and notification of customers. The notice described the product, problem and actions to be taken. The customers were instructed to always acquire both the treatment port and the open port images BEFORE displaying the digital graticule, when using a standard double exposure template; and to advise the appropriate personnel working in their radiotherapy department of the content of this letter. Special instructions for customers outside the USA and Canada: these customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems, once they have read this document. Varian is developing a correction for this issue and a Customer Service rep will contact the customers when the correction is available to schedule its installation on their systems. If you have any questions, contact USA and Canada at 1-888-827-4265; Europe: +41 41 749 8844; Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: China.apps.helpdesk@varian.com; Japan: Japan-Apps.Helpdesk@varian.com and Latin America: soporte.al@varian.com or Internet: Oncology systems customer site: www.myvarian.com and Varian Medical Systems public site: www.varian.com.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

1486 devices

Distribution

Worldwide distribution: USA (nationwide) and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmar

Date initiated

2011-11-23

Date posted

2012-01-11

Date terminated

2014-08-06

Location

Palo Alto, CA

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