Z-0526-2015Class II

Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of...

Name: Z-0526-2015 Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of...
Creator: Varian Medical Systems, Inc.
Published: 2014-04-30
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2014-04-30 / Terminated / root cause: supplier

FDA source

Varian Medical Systems, Inc. began a recall of Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and... on 2014-04-30. FDA classified it as Class II and gives the reason as "Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0526-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Posted: 2014-12-16
Terminated: 2015-03-16
Recalling firm: Varian Medical Systems, Inc.
Product: Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land marks.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the High Voltage Module.
Root cause tag: supplier
FDA root cause: Component change control
Action: Varian will work with affected customers to establish schedules that minimize impact to their clinic's treatment schedule and send Field Service Engineers with the required hardware to each affected site to make the modification.
Quantity in commerce: 32 units
Distribution: Worldwide Distribution.
Product codes and lots: Part Number P1003290001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0526-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code IYE

K042720Class IIOn-Board Imager DeviceVarian Medical Systems / cleared 2004-10-29

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)