Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0840-03

MagicView 1000 and Magic View Mondo. Digital Image Communication

Siemens Medical Solutions USA, Inc. / initiated 2003-07-03 / Terminated

Siemens Medical Solutions USA, Inc began a recall of MagicView 1000 and Magic View Mondo. Digital Image Communication on . The reason FDA records is "Potential error can occur with the 3D post processing options MPR, MIP, and VRT". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0840-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Product code
LMD System, Digital Image Communications, Radiological
Reason for recall
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
FDA root cause
Other
Action
Siemens informed all users via a customer safety adv isory letter sent certified mail on 7/3/2002.
Quantity in commerce
159 units
Distribution
Units were distributed to hospitals and clinics throughout the nation. There are 11 government hospitals.
Product codes and lots
Serial Numbers: 1017; 1030; 1052; 1053; 1054; 1063; 1066; 1085; 1086; 1052; 1060; 1085; 1088; 1090; 1091; 1093; 1096; 1099; 1100; 1101; 1102; 1104; 1105; 1106; 1109; 1114; 1116; 1119; 1126; 1127; 1133; 1134; 1135; 1136; 1137; 1138; 1139; 1145; 1148; 1149; 1150; 1151; 1152; 1153; 1154; 1155; 1156; 1161; 1165; 1168; 1171; 1172; 1173; 1174; 1177; 1186; 1187; 1189; 1246; 1262; 1265; 1266; 1268; 1271; 1274; 1275; 1293; 1294; 1295; 1296; 1297; 1300; 1301; 1309; 1310; 1318; 1323; 1324; 1326; 1328; 1333; 1336; 1341; 1343; 1344; 1346; 1347; 1356; 1366; 1367; 1368; 1369; 1373; 1374; 1375; 1376; 1377; 1381; 1382; 1383; 1384; 1385; 1386; 1387; 1388; 1390; 1391; 1395; 1396; 1399; 1402; 1406; 1410; 1427; 1428; 1441; 1442; 1445; 1452; 1453; 1454; 1455; 1456; 1457; 1458; 1459; 1460; 1461; 1462; 1464; 1467; 1468; 1470; 1471; 1472; 1481; 1485; 1497; 4109; 4111; 4138; Govt. accounts: 1031; 1057; 1062; 1098; 1108; 1162; 1167; 1169; 1254; 1255; 1303; 1320; 1404; 1429; 1478; 1488; 1592; 1730.