PRIMUS HI #04504200 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 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832, 3667, 3924, 3949, 4036, 70-4185, 5153, 3361, 3979, 3657, 3679

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