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U.S. Department of Health and Human Services

Class 3 Device Recall Siemen MagicView

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  Class 3 Device Recall Siemen MagicView see related information
Date Initiated by Firm July 03, 2003
Date Posted May 16, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-0840-03
Recall Event ID 26057
510(K)Number K935694  
Product Classification System, Digital Image Communications, Radiological - Product Code LMD
Product MagicView 1000 and Magic View Mondo. Digital Image Communication.
Code Information 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.  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Parkway
Malvern PA 19355
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LMD and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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