Events

Rappel de Device Recall CellaVision DM96, DM1200, DM9600 and DI60

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 Cellavision AB.

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
    80137
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2184-2018
  • Date de mise en oeuvre de l'événement
    2017-12-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164663
  • 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
    Device, automated cell-locating - Product Code JOY
  • Cause
    A software malfunction was found where wbc, rbc and plt comments added after a slide is signed, are not sent to the lis. this can only occur where customers process multiple slides per blood sample.
  • Action
    CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision (service@cellavision.se)

Device

Device Recall CellaVision DM96, DM1200, DM9600 and DI60
  • Modèle / numéro de série
    Versions 6.0.1 or 6.0.2
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide in the states of FL, IL, NY, and NC
  • Description du dispositif
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 || Product Usage: || The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
  • Manufacturer
    Cellavision AB

Manufacturer

Cellavision AB
  • Adresse du fabricant
    Cellavision AB, Forskningsbyn Ideon, Scheelevagen 19a, Lund Sweden
  • Société-mère du fabricant (2017)
    CellaVision AB
  • Source
    USFDA