Events

Retiro De Equipo (Recall) de Device Recall Samsung GU60A system Digital Xray Imaging Systems

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 NeuroLogica Corporation.

¿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
    77384
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3036-2017
  • Fecha de inicio del evento
    2017-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155900
  • 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, stationary - Product Code KPR
  • Causa
    When performing the stitching function on gu60a system, unintended area is exposed to radiation.
  • Acción
    Neurologica will bring defect into compliance : 1.All facilities were notified via a customer notification letter. 2.Samsung will release improved software to avoid unintended exposure. When setting the stitching area, if there is an over exposed area, the height of the swivel arm will be lowered over the exposed area and the first region (first image) will be collimated by the bottom blade. 3.A software patch was developed: SW3.01 was released on 05/08/2017 and SW1.00 was released on 07/28/17. 4.The software patch will be installed on the affected devices. 5.Samsung has provided the statement and assurance that all corrections will be performed free of charge. 6.All units will be provided with updated software by November 11, 2017. For further questions, please call (978) 564-8500.

Device

Device Recall Samsung GU60A system Digital Xray Imaging Systems
  • Modelo / Serial
    Serial Numbers: S03PM3ADA00001T S03PM3ADC00001H S03PM3ADC00002J S03PM3AF200004X S03PM3AF200005N S03PM3AF200006E S03PM3AF300001K S03PM3AF300002Z S03PM3AF300007X S08HM3AF300001J S08HM3AF300002B S08HM3AF300004H S08HM3EF400001W S08HM3EF400002A S08HM3DF400002Y S08HM3EF400003H S08HM3EF400004K S08HM3DF400003R S08HM3DF400004B S08HM3EF400005E S08HM3DF500001B S08HM3CF500001T S08HM3EF500001K S08HM3DF500002F S08HM3BF500001L S08HM3BF500002N S08HM3CF600001R S08HM3CF600003V S08HM3DF600002P S08HM3DF600001H S08HM3DF600003L S08HM3DF600004F S08HM3DF600005Y S08HM3DF600006W 508UM3BF700001L S08HM3AFB00001Y 508UM3BG100002K 508UM3BG100001T 50FFM3AG200001V 50FFM3AG200002K 50FFM3AG200003P 50FFM3AG200004E 50FFM3AG200005J 50FFM3AG300001X 50FFM3BG600003E 50FFM3BG600002V 50FFM3BG600001A 50FFM3CG700004E 50FFM3CG700002B 50FFM3CG700003M 50FFM3CG700001P 50FFM3CG700006T 50FFM3CG700007J 50FFM3CG700005A 50FFM3CG700008N 50FFM3AG700002L 50FFM3AG700001Y 50FFM3AG800004K
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Samsung GU60A system- || Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
  • Manufacturer
    NeuroLogica Corporation

Manufacturer

NeuroLogica Corporation
  • Dirección del fabricante
    NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
  • Empresa matriz del fabricante (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA