Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.
Recall
- Recall Number
- Z-0516-2012
- Event Number
- 60684
- Firm
- Varian Medical Systems, Inc. Oncology Systems
- FEI Number
- 2916710
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 23, 2011
- Posted
- January 11, 2012
- Terminated
- August 6, 2014
- Address
- 911 Hansen Way, Palo Alto, CA, 94304-1028
Description
Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.
An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.
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: [email protected]; Australia/New Zealand: [email protected]; Europe: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected] and Latin America: [email protected] or Internet: Oncology systems customer site: www.myvarian.com and Varian Medical Systems public site: www.varian.com.
Worldwide distribution: USA (nationwide) and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France,, Georgia, Germany,Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Lativia, Macedonia, Malaysia, Martinique, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
1486 devices