Events

Rappel de CT LightSpeed 16 and Discovery ST Pet/CT DST

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 GE Healthcare.

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
    71167
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1623-2015
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Date de publication de l'événement
    2015-05-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136320
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT  00000344962CN6 INSIGHTPCT1356
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to the states of MN, FL & TX.
  • Description du dispositif
    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
  • Adresse du fabricant
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA