Device Recall Biograph 16

  • Model / Serial
    Serial Numbers: 1300, 1301, 1302, 1303, 1305, 1306, 1307, 1308, 1309, 1310, 1311, 1312, 1313, 1315, 1316, 1317, 1318, 1319, 1320, 1321, 1322, 1323, 1324, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1359, 1360, 1361, 1362, 1363, 1364, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1384, 1385, 1386, 1387, 1388, 1389, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1424, 1425, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1449, 601055, 701068, 701069, P0007130-0401002, P0007130-0401003, P0007130-0401004, P0007130-0401005, P0007130-0401006, P0007130-0401007, P0007130-0401008, P0007130-0401009, P0007130-0401010, P0007130-0401012, P0007130-0401013, P0007130-0401014, P0007130-0401015, P0007130-0401016, P0007130-0401021, P0007130-0401031, P0007130-0501056, and P0007130-0501075
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.
  • Product Description
    Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA