Events

Retiro De Equipo (Recall) de Device Recall Symbia T Series SPECTCT System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    53919
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0584-2010
  • Fecha de inicio del evento
    2009-12-11
  • Fecha de publicación del evento
    2009-12-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86868
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    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.
  • Acción
    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 T Series SPECTCT System
  • Modelo / Serial
    Part: 8717733, Serial Numbers: 1015, 1027, 1037, 1046, 1061, 1065, 1068, 1072, 1074, 1076, 1077, 1078, 1092, 1095, 1102, 1120, 1121, 1122, 1127, 1128, 1131, 1136, 1143, 1145, 1146, 1148, 1151, 1153, 1169, 1171, 1172, 1174, 1175, 1179, 1190 and 1192;  Part: 10275007, Serial Numbers: 1021, 1030, 1034, 1039, 1052, 1060, 1061, 1064, 1065, 1070, 1071, 1074, 1079, 1085, 1091, 1093, 1098;  part 10275008, serial number 1003, 1005, 1011, 1013, 1014, 1015, 1023, 1038, 1039, 1044, 1046, 1056, 1065, 1066, 1068, 1071, 1072, 1076, 1082, 1084, 1094, 1097 and 1105;  Part: 10275009, Serial Numbers: 1003, 1004, 1008, 1009, 1015, 1026, 1027, 1033, 1034, 1037, 1040, 1047, 1053, 1058, 1066 and 1071; and  Part 10275010, Serial Numbers: 1008, 1011, 1018, 1026 and 1029.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; 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.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA