Events

Rappel de Device Recall GE Healthcare, Precision MPi fluoroscopic imaging systems.

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
    71574
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2123-2015
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • Date de publication de l'événement
    2015-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138744
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    A reported incident of a monitor that fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. recall affects the single and dual lcd monitor suspensions used on precision 500d classical r & f system, precision rxi 23a/32a analog system, precision rxi digital system and precision mpi fluoroscopic imaging systems.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s). 1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. 3. Contact your GE Healthcare representative to inform them of any loose or missing screws. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, Precision MPi fluoroscopic imaging systems.
  • Modèle / numéro de série
    Mfg Lot or Serial # 00000000687MC4 00000001286MC4 00000004134MC3 00000003843MC0 00000003890MC1 00000004159MC0 00000004689MC6 00000001505MC7 00000003889MC3 00000003937MC0 00000002207MC9 00000003931MC3 00000001452MC2 00000003847MC1 00000004427MC1 00000004649MC0 00000003642MC6 00000001343MC3 00000004650MC8 00000004161MC6 00000001459MC7 00000001658MC4 00000001333MC4 00000003511MC3 00000001430MC8 00000001057MC9 00000001055MC3 00000001275MC7 00000001420MC9 00000001406MC8 00000001889MC5 00000001408MC4 00000003936MC2 00000001101MC5 00000001415MC9 00000001746MC7 00000001419MC1 00000004701MC9 0000000470FMC9 00000004700MC1 00000000952MC2 00000001302MC9 00000000921MC7
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
  • Description du dispositif
    GE Healthcare, Precision MPi fluoroscopic imaging systems.
  • 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