Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX,

FDA device recall Z-0886-2011 · posted 2011-01-08 · Terminated

Recall details

Recalling firm

Varian Medical Systems Oncology Systems

Reason for recall

The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.

Action taken

Varian sent a Customer Technical Bulletin letter to all affected users on May 27, 2010, and was also posted to Varian's customer support site: http://www.MyVarian.com. The letter identified the product, the problem, and provided instructions on the recall. Customers were instructed to return the proof of notification (via completed "Proof of Notification Form or appropriate Postal system certified receipt of delivery to Varian. For questions regarding this recall call 650-483-3153.

Root cause

Other

Status

Terminated

Product code

GKZ

Distribution

Worldwide Distribution - USA including CA, TX, IL, GA, NJ, and NV and the countries of Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East,

Date initiated

2010-06-10

Date posted

2011-01-08

Date terminated

2011-12-23

Location

Palo Alto, CA

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