Z-0888-2011

Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use...

Name: Z-0888-2011 Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use...
Creator: Varian Medical Systems Oncology Systems
Published: 2009-01-26
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2009-01-26 / Terminated / root cause: design

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the... on 2009-01-26. The reason FDA records is "Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0888-2011
Status: Terminated
Initiated: 2009-01-26
Posted: 2011-01-10
Terminated: 2012-02-24
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
Root cause tag: design
FDA root cause: Device Design
Action: Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations.
Quantity in commerce: 3 units
Distribution: Product was distributed to 3 consignees in Florida and Wisconsin.
Product codes and lots: Codes HZ5071, HZ59014 and HZ59017.

Product code IYE

K071360Class IIOptical Guidance PlatformVarian Medical Systems, Inc. / cleared 2007-06-08

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)