Events

Rappel de Device Recall Biograph 16

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    45153
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0246-2008
  • Date de mise en oeuvre de l'événement
    2007-07-23
  • Date de publication de l'événement
    2008-01-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64973
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    PET/CT Scanner - Product Code KPS
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Siemens Medical Solutions USA Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA