Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.
FDA Recall Z-1206-06 · Posted 2006-07-06
Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-06-06
Date Terminated2007-12-03
Product Quantity217 units
Reason for Recall
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
Firm Action
The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.
Root Cause
Other
Distribution Pattern
Worldwide
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.