Recall Z-0526-2015— Varian Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2014-04-30, terminated 2015-03-16. It names one FDA 510(k) clearance: K042720. 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.. 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..
- Recalling firm
- Varian Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-30
- Terminated
- 2015-03-16
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.