Device Recall Surface Applicator Set with Leipzigstyle Cone 의 리콜

Recall

71450

Class 2

Z-1829-2015

2015-05-18

2015-06-23

Terminated

United States

2016-01-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137839

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.

All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.