Atlas FDA

Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D,

FDA device recall Z-1206-06 · posted 2006-07-06 · Terminated

Recall details

Recalling firm
Varian Medical Systems Inc
Reason for recall
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
Action taken
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
Status
Terminated
Product code
IYE
Quantity affected
217 units
Distribution
Worldwide
Date initiated
2006-06-06
Date posted
2006-07-06
Date terminated
2007-12-03
Location
Palo Alto, CA

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Related 510(k) clearances

RecordFirmDate
CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) (K862645)Varian Assoc., Inc.1986-10-03