Z-0246-2008

Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA...

Name: Z-0246-2008 Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA...
Creator: Siemens Medical Solutions USA Inc
Published: 2007-07-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-07-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA Inc began a recall of Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA... on 2007-07-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0246-2008
Status: Terminated
Initiated: 2007-07-23
Posted: 2008-01-04
Terminated: 2009-09-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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
Product code: KPS System, Tomography, Computed, Emission
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)
Root cause tag: software
FDA root 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: 162 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.
Product codes and lots: 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 code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)