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.
This recall has been terminated (originally issued December 16, 2014).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- April 30, 2014
- Posted
- December 16, 2014
- Terminated
- March 16, 2015
- Recall Number
- Z-0526-2015
- Quantity
- 32 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution.
Lot / Code Info
Part Number P1003290001
Root Cause
Component change control
Action Taken
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.
More recalls by Varian Medical Systems, Inc.
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definitio...
Aug 12, 2019
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only...
Dec 26, 2018
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based...
Jan 10, 2017