Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D
FDA Recall Z-1074-2007 · Posted 2007-07-12
Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-05-02
Date Terminated2010-11-27
Product Quantity209 units
Reason for Recall
The wedge tray may slip out of the Clinac interface mount during gantry rotation.
Firm Action
The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.
Root Cause
Process control
Distribution Pattern
Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, Switzerland, UAE, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.