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U.S. Department of Health and Human Services

Class 2 Device Recall Segmented Cylinder Applicator Set

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  Class 2 Device Recall Segmented Cylinder Applicator Set see related information
Date Initiated by Firm April 11, 0013
Date Posted May 15, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-1324-2013
Recall Event ID 64986
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)

Product Usage: Usage:
Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Code Information Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Mark Kattman
434-977-8495
Manufacturer Reason
for Recall		 Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems, Inc. notified customers of the recall with 'Urgent Medical Device Correction Urgent Field Safety Notice," dated 4/11/13, and delivered by mail to customers. The notice identified the product, problem, and instructions for the customers. Varian Medical Systems, Inc. informed customers of the possible malfunction of the GM11004150 Segmented Cylinder Applicator Set for pulsed dose rate brachytherapy treatment, with codes H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387. The notice instructed customers to cease use of the Segmented Cylinder Applicator Set and return the devices along with a completed proof of notification form (included with the recall notice) to the recalling firm.
Quantity in Commerce 21 devices
Distribution Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
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.
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