Z-0910-2011

C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX...

Name: Z-0910-2011 C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX...
Creator: Varian Medical Systems Oncology Systems
Published: 2009-10-08
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2009-10-08 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems Oncology Systems began a recall of C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA... on 2009-10-08. The reason FDA records is "Product may deliver radiation treatment to areas larger than intended,to healthy tissue". 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-0910-2011
Status: Terminated
Initiated: 2009-10-08
Posted: 2011-01-18
Terminated: 2012-02-24
Recalling firm: Varian Medical Systems, Inc.
Product: C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.
Quantity in commerce: 5208 units
Distribution: Worldwide Distribution
Product codes and lots: to be added.

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)