ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information: Serial Numbers 5350, 5410, 5419, 5481, 5500, 5488, 5532, 5540, 5548, 5572, 5590, 5601, 5630, 5640, 5657, 5699, 5707, 5737, 5743, 5748, 5755, 5784, 5823, 5843, 5844, 5851, 5899, 5833, 5894, 5830

Distribution pattern: Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming