Reported Dec 24, 2014 · Terminated
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number P1003290001
- Amount recalled
- 32 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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