medical Class II Updated 2020-04-15

Siemens Medical Solutions USA, Inc recalls ARTISTE MV System Model #8139789 with Digital LINAC Systems

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: 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
Lot/Code Info: 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
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