Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0526-2015

April 30, 2014

Class II

Product summary

Firm
Varian Medical Systems, Inc.
Event
Event 69637
Status
Terminated
Classification
Class II
Quantity
32 units
Official record key
device-enforcement:Z-0526-2015

Official wording

Reason: 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.

Code information: Part Number P1003290001

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.