Device product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Z-1829-2015
Product summary
- Event
- Event 71450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46
- Official record key
device-enforcement:Z-1829-2015
Official wording
Reason: 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
Code information: JAQ
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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