Events

Retiro De Equipo (Recall) de CT LightSpeed 16 and Discovery ST Pet/CT DST

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 GE Healthcare.

¿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
    71167
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1623-2015
  • Fecha de inicio del evento
    2015-04-22
  • Fecha de publicación del evento
    2015-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136320
  • 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
    Ge healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain lightspeed 16 ct scanner or pet/ct dst scanner.. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were expelled. there were no incidents or injuries reported as a res.
  • Acción
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 25461 dated April 22, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use their device. If the error occurs, then stop using the system and call a service representative to bring the system back into proper operation. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATED: Consignees were sent on 5/14/2015 a second GE Healthcare "Urgent Medical Device Correction" letter dated May 14th, 2015. The letter was to incorporate and additional unit being recalled.

Device

CT LightSpeed 16 and Discovery ST Pet/CT DST
  • Modelo / Serial
    Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT  00000344962CN6 INSIGHTPCT1356
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of MN, FL & TX.
  • Descripción del producto
    CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. || Designed to be a head and whole body CT scanner utilizing a new solid state detector.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA