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U.S. Department of Health and Human Services

Class 2 Device Recall Flexible Probe with Blocking Washer

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  Class 2 Device Recall Flexible Probe with Blocking Washer see related information
Date Initiated by Firm July 13, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 on June 20, 2012
Recall Number Z-3055-2011
Recall Event ID 59402
510(K)Number K033371  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product Flexible Probe with Blocking Washer (part of Segmented Cylinder Set)

The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
Code Information Part number GM11002420; (part of Segmented Cyclinder Set, GM11004150). All lots.
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
Quantity in Commerce 1019 total
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
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