Z-1206-06

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

Name: Z-1206-06 Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers...
Creator: Varian Medical Systems Inc
Published: 2006-06-06
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2006-06-06 / Terminated

FDA source

Varian Medical Systems Inc began a recall of 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... on 2006-06-06. The reason FDA records is "Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1206-06
Status: Terminated
Initiated: 2006-06-06
Posted: 2006-07-06
Terminated: 2007-12-03
Recalling firm: Varian Medical Systems, Inc.
Product: 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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
FDA root cause: Other
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.
Quantity in commerce: 217 units
Distribution: Worldwide
Product codes and lots: All lots

Product code IYE

K862645Class IIClinac (R) C Series (400C, 600C, 2100C, 2500C)Varian Assoc., Inc. / cleared 1986-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)