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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 May 20, 2010
Date Posted November 23, 2011
Recall Status1 Terminated 3 on December 05, 2011
Recall Number Z-0282-2012
Recall Event ID 59913
510(K)Number K033371  
Product Classification Flexible Probe - Product Code JAQ
Product Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)
Code Information Lot number Y01 to E19
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Mark Kattmann
434-977-8495
Manufacturer Reason
for Recall		 The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.
FDA Determined
Cause 2		 Labeling Change Control
Action Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.
Quantity in Commerce 81 parts
Distribution Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India
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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