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U.S. Department of Health and Human Services

Class 2 Device Recall Surface Applicator Set with Leipzigstyle Cone

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  Class 2 Device Recall Surface Applicator Set with Leipzigstyle Cone see related information
Date Initiated by Firm May 18, 2015
Date Posted June 23, 2015
Recall Status1 Terminated 3 on January 26, 2016
Recall Number Z-1829-2015
Recall Event ID 71450
510(K)Number K123815  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product Surface Applicator Set with Leipzig-style Cone.

Brachytherapy applicator set.
Code Information JAQ
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
501 Locust Ave
Charlottesville VA 22902-4869
For Additional Information Contact Rachel Forsberg
434-951-8635
Manufacturer 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
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 46
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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