Z-1829-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2015
- Initiation Date
- May 18, 2015
- Termination Date
- January 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Reason for Recall
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
Distribution Pattern
Worldwide Distribution.
Code Information
JAQ