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FDA Medical Device Recalls (openFDA)

Siemens Medical Solutions USA, Inc: MagicView 1000 and Magic View Mondo. Digital Image Communication.

Recall number
Z-0840-03
Recalling firm
Siemens Medical Solutions USA, Inc
Product
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Status
Terminated
Initiated
2003-07-03
Posted
2003-05-16
Terminated
2006-10-03
Reason
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
Root cause
Other
Action
Siemens informed all users via a customer safety adv isory letter sent certified mail on 7/3/2002.
Quantity
159 units
Distribution
Units were distributed to hospitals and clinics throughout the nation. There are 11 government hospitals.
Lot, serial or model codes
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.
510(k) numbers
["K935694"]
PMA numbers
not on file
Product code
LMD
Firm FEI
2240869
Firm city
Malvern
Firm state
PA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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