Recall Z-1829-2015— Varian Medical Systems Inc

Name: FDA recall Z-1829-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-18

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems Inc, initiated 2015-05-18, terminated 2016-01-26. It names one FDA 510(k) clearance: K123815. Product: Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.. 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.

Recalling firm: Varian Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Terminated: 2016-01-26
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K123815 — SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONEVarian Medical Systems, Inc.·cleared 2013-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.