Z-1003-2011

Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and...

Name: Z-1003-2011 Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and...
Creator: Varian Medical Systems Oncology Systems
Published: 2010-04-19
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-04-19 / Terminated / root cause: labeling and UDI

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo... on 2010-04-19. The reason FDA records is "The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1003-2011
Status: Terminated
Initiated: 2010-04-19
Posted: 2011-02-01
Terminated: 2011-12-23
Recalling firm: Varian Medical Systems, Inc.
Product: Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Varian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office. For questions regarding this recall call 650-483-3153.
Quantity in commerce: 13
Distribution: Worldwide Distribution - Japan only
Product codes and lots: Product Codes: H690002, H694936, H696287, H695791, H694466, H696406, H694937, H697423, H695540, H695617, H695747, H695780, H696166

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)