Class 2 Device Recall Biograph 6

• Date Initiated by Firm: July 23, 2007
• Date Posted: January 04, 2008
• Recall Status: Terminated on September 11, 2009
• Recall Number: Z-0249-2008
• Recall Event ID: 45153
• 510(K)Number: K940478 K962797 K002584 K003541
• Product Classification: PET/CT Scanner - Product Code KPS
• Product: Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
• Code Information: Serial Numbers: 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1307, 1309, 1310, 1311, 1312, 1313, 1315, 1316, 1317, 1318, 1320, 1321, 1322, 1323, 1324, 1325, 1326, 1327, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1358, 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, 1390, 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, 1423, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1450, 1451, 1452, 1455, 1456, 1457, 1458, 1459, 1460, 1461, 1462, 1464, 1465, 1466, 1467, 401011, 401013, 401030, 601033, 701065, 701073, P0006939-0401004, P0006939-0401006, P0006939-0401009, P0006939-0401015, P0006939-0401016, P0006939-0401017, P0006939-0401026, and P0006939-0401034
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA Inc; 810 Innovation Dr; Knoxville TN 37932-2562
• For Additional Information Contact: Maria Ebio; 865-218-2534
• Manufacturer Reason for Recall: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)
• FDA Determined Cause: Software design
• Action: A certified letter-Urgent Device Correction- dated June 15, 2007 was sent to all affected consignees on July 23, 2007 informing them of the problem (PET iterative reconstruction algorithm) and requesting as a short term fix that they discontinue the practice of operating using protocols other than the default Biograph. Software upgrades as the long term fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.
• Quantity in Commerce: 175 units
• 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.
• 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 = KPS and Original Applicant = CAO GROUP, INC.; 510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.