Recall Z-0526-2015 · IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
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.
| Date | Dec 16, 2014 (initiated Apr 30, 2014) |
| Status | Terminated |
| 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. |
| 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 | 32 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042720 | ON-BOARD IMAGER DEVICE Varian Medical Systems, Oct 29, 2004 |