Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Reported: July 1, 2015 Initiated: May 18, 2015 #Z-1829-2015
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
Details
- Recalling Firm
- Varian Medical Systems Inc
- Units Affected
- 46
- Distribution
- Worldwide Distribution.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.. Recalled by Varian Medical Systems Inc. Units affected: 46.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1829-2015.
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