Device Recall Regulation Number 892.5700

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

Radiology Devices

2

No

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.

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.