Siemens Medical Solutions USA, Inc recalls PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Recalled April 15, 2020 · FDA recall Z-1680-2020 · Siemens Medical Solutions USA

Hazard

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. · FDA Class II

Units

230,001

Sold at

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

Description

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

Product

PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Manufacturer(s)

Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →