FDA Device

ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.

Hazard

Unintended movement of the system table and/or C arm.

What You Should Do

Remedy

Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.

Products

ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.
Brand
Siemens Medical Solutions USA, Inc
UPC
Model number 9359142. Serial numbers: 999, 1038, 1062, 1068, 1073, 1104, 1106A, 1111, 1154, 1163, 1164, 1167, 1188, 1194, 1214, 1220, 1225, 1227, 1250, 1251, 1264, 1266, 1275, 1287, 1291, 1300, 1301, 1303, 1304, 1317, 1327, 1347, 1362, 1363, 1368, 1370, 1372, 1375, 1381, 1384, 1390, 1397, 1399, 1400, 1403, 1407, 1408, 1413, 1431, 1437, ASPP1_PT 01176, AS_P1_PT 01179, and AS2P8_PT 01185.

Units Affected

53 units