Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1829-2015 — Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

U.S. FDA — Device Enforcement · United States · 2015-05-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1829-2015
Date of alert
2015-05-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Varian Medical Systems Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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