Medrad Mark 7 Arterion Injection System

Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH.  Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

Cardiovascular Devices

2

No

Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.