Events

Rappel de Device Recall Symbia T 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
    51483
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1649-2009
  • Date de mise en oeuvre de l'événement
    2009-03-11
  • Date de publication de l'événement
    2009-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80495
  • 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
    Single-Photon Emission Computed Tomography - Product Code KPS
  • Cause
    Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.E. the patient or pallet is into the field of view.
  • Action
    Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.

Device

Device Recall Symbia T Series SPECT System
  • Modèle / numéro de série
    Part number 8717733, serial numbers 1019, 1020, 1021, 1023, 1041, 1042, 1043, 1052, 1054, 1067, 1072, 1073, 1077, 1090, 1091, 1103, 1106, 1109, 1121, 1125, 1127, 1128, 1135, 1138, 1140, 1147, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1170, 1171, 1173, 1174, 1175, 1178, 1180, 1181, 1184, 1187, 1191, 1193, 1194, 1196, 1198, 1199, 1202, 1204, 1208, and 1210;  Part number 10275007, serial numbers 1001, 1006, 1007, 1009, 1011, 1012, 1014, 1015, 1018, 1023, 1026, 1029, 1030, 1032, 1034, 1035, 1038, 1039, 1040, 1041, 1043, 1044, 1053, 1057, 1058, 1059, 1060, 1061, 1064, 1065, 1069, and 1071 Part number 1075008, serial numbers 1002, 1003, 1009, 1010, 1011, 1017, 1018, 1019, 1020, 1023, 1024, 1031, 1035, 1038, 1041, 1047, 1055, 1056, 1057, 1058, 1063, 1065, 1066, 1069, 1071, and 1076;  Part number 10275009, serial numbers 1008, 1013, 1015, 1017, 1019, 1020, 1022, 1024, 1026, 1027, 1028, 1029, 1030, 1032, 1034, 1039, 1040, 1044, 1046, 1047, 1050, 1051, 1054, 1055, and 1056;  Part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1006, 1007, 1008, 1010, 1011, 1012, and 1013
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.
  • Description du dispositif
    Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System;
  • 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