PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 24, 2014 Initiated: April 30, 2014 #Z-0526-2015

Product Description

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.

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.

Details

Units Affected
32 units
Distribution
Worldwide Distribution.
Location
Palo Alto, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Varian Medical Systems, Inc.. Units affected: 32 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0526-2015.