Recalls / —
—#26952
Product
MagicView 1000 and Magic View Mondo. Digital Image Communication.
- FDA product code
- LMD — System, Digital Image Communications, Radiological
- Device class
- Class 1
- Medical specialty
- Radiology
- 510(k) numbers
- K935694
- Affected lot / code info
- 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.
Why it was recalled
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
Root cause (FDA determination)
Other
Action the firm took
Siemens informed all users via a customer safety adv isory letter sent certified mail on 7/3/2002.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Parkway, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Units were distributed to hospitals and clinics throughout the nation. There are 11 government hospitals.
Timeline
- Recall initiated
- 2003-07-03
- Posted by FDA
- 2003-05-16
- Terminated
- 2006-10-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #26952. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.