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.
FDA Recall Z-0526-2015 · Posted 2014-12-16
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Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-04-30
Date Terminated2015-03-16
Product Quantity32 units
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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