Z-0194-2007

Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s...

Name: Z-0194-2007 Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s...
Creator: Varian Medical Systems Inc
Published: 2006-08-31
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2006-08-31 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems Inc began a recall of Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX) on 2006-08-31. The reason FDA records is "The chain holding the device gantry in position may break". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0194-2007
Status: Terminated
Initiated: 2006-08-31
Posted: 2006-11-16
Terminated: 2007-12-04
Recalling firm: Varian Medical Systems, Inc.
Product: Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The chain holding the device gantry in position may break.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in commerce: 254 units
Distribution: Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.
Product codes and lots: Serial numbers H272325, H291060, H271879, H273040, H272187, H272434

Product code IYE

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)