Events

Recall of Device Recall Biograph 16

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45153
  • Event Risk Class
    Class 2
  • Event Number
    Z-0246-2008
  • Event Initiated Date
    2007-07-23
  • Event Date Posted
    2008-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64973
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    PET/CT Scanner - Product Code KPS
  • Reason
    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).
  • 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.

Device

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
    Radiology Devices
  • 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
    Siemens Medical Solutions USA Inc

Manufacturer

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