Events

Rappel de Device Recall Symbia S Series SPECT System

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
    53919
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0583-2010
  • Date de mise en oeuvre de l'événement
    2009-12-11
  • Date de publication de l'événement
    2009-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86867
  • 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
    System, tomography, computed, emission - Product Code KPS
  • Cause
    Some of the hand controllers of the symbia s & t systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
  • Action
    Siemens issued an Urgent Field Correction Recall letters dated November 18, 2009 and December 11, 2009 to the affected users of the Symbia S and Symbia T Systems, respectivley. The customers were advised of precautionary measures and that Siemens will replace the affected device. They also were advised that a Siemens Customer Service Representative would contact them within a few days to schedule a replacement of the device. For further information, contact Siemens Medical Solutions USA, Inc. at 1-800-888-7436 (USA).

Device

Device Recall Symbia S Series SPECT System
  • Modèle / numéro de série
    Part: 8717741, Serial Numbers: 1006, 1007, 1008, 1009, 1019, 1021, 1022, 1024, 1032, 1033, 1034, 1035, 1038, 1044, 1045, 1049, 1051, 1054, 1057, 1058, 1062, 1067, 1069, 1073, 1081, 1082, 1083, 1088, 1092, 1094, 1095, 1103, 1104, 1115, 1116, 1121, 1124, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1145, 1149, 1150, 1151, 1152, 1156, 1157, 1159, 1160, 1161, 1162, 1163, 1167, 1169, 1179, 1181, 1182, 1183, 1184, 1186, 1187, 1190, 1191, 1197, 1199, 1201, 1207, 1211, 1214, 1215, 1216, 1220, 1224, 1225, 1229, 1230, 1232, 1242, 1243, 1245, 1246, 1252, 1253, 1254, 1255, 1258, 1267, 1269, 1271, 1275, 1277, 1282, 1288, 1293, 1299, 1304, 1312, 1313, 1317, 1320, 1321, 1322, 1323, 1327, 1329, 1331, 1332, 1334, 1343, 1348, 1349, 1363, 1364, 1366, 1368, 1372, 1376, 1380, 1385, 1386, 1387, 1389, 1392, 1398, 1399, 1402, 1404, 1405, 1409, 1411 and 1412.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Finland, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Mexico, Netherlands, Norway, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, Venezuela and Vietnam.
  • Description du dispositif
    Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061. || Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA