Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
This recall has been terminated (originally issued March 12, 2012).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- January 5, 2012
- Posted
- March 12, 2012
- Terminated
- November 21, 2012
- Recall Number
- Z-1200-2012
- Quantity
- 122 total units
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
Distribution
Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
Lot / Code Info
All lots of the components are recalled. Components are used as adapters for the Varian Afterloaders with the following serial numbers: H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583
Root Cause
Device Design
Action Taken
Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.