medical Class II Updated 2020-04-15

Siemens Medical Solutions USA, Inc recalls ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCO

Recalled Product

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 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 3905, 70-4077, 4082, 70-4283, 70-4368, 5177, 3922, 5120, 5170, 5179, 5205, 5226, 5245, 5282, 5300, 5343, 5385, 5391, 5506, 5665, 4078, 70-4143, 70-4235, 70-4296, 70-4344, 5154, 5281, 5417, 3755, 3761, 3802, 3801, 3901, 3981, 4072, 70-4174, 70-4354, 70-4378, 5087, 5088, 5096, 5095, 5098, 5118, 5148, 5396, 5157, 5821
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