Events

Retiro De Equipo (Recall) de PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT

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 CTI PET Systems 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
    30802
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0547-05
  • Fecha de inicio del evento
    2004-05-27
  • Fecha de publicación del evento
    2005-02-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36628
  • 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, Tomography, Computed, Emission - Product Code KPS
  • Causa
    Misalignment of ct and pet scans from performing additional ct scans may produce an incorrect fused data set. in performing additional ct scans, the original pet and ct scans may become misaligned and produce an incorrect fused data set.
  • Acción
    Written notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.

Device

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography)...
  • Modelo / Serial
    0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007,  096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015,  096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007,  096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014,  096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002,  214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016,  214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006,  214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013,  214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021,  214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028,  214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035,  214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042,  216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015,  216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022,  216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Germany, Spain, Italy, Korea and Canada
  • Descripción del producto
    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT
  • Manufacturer
    CTI PET Systems Inc

Manufacturer

CTI PET Systems Inc
  • Dirección del fabricante
    CTI PET Systems Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA