Reported Jul 1, 2015 · Terminated
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
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 · 501 Locust Ave · Charlottesville, VA · 22902-4869
Is this the product you have?
- Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
- Lot codes and dates
- JAQ
- Amount recalled
- 46
Why it was recalled
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
This product could cause temporary or reversible health problems — stop using it.
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