Events

Rappel de Device Recall The Selenia Full Field Digital Mammography System

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 Lorad, A Hologic, Inc..

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
    47386
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1546-2008
  • Date de mise en oeuvre de l'événement
    2008-02-28
  • Date de publication de l'événement
    2008-05-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-02-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69385
  • 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
    Full field digital, system, x-ray, mammographic - Product Code MUE
  • Cause
    Marker misalignment: the new software version contained a magnification factor that shows cad markers misaligned with the identified indications. the marked area is misaligned up to 2cm from the indication.
  • Action
    Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.

Device

Device Recall The Selenia Full Field Digital Mammography System
  • Modèle / numéro de série
    Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada and the Republic of Korea.
  • Description du dispositif
    Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810
  • Manufacturer
    Lorad, A Hologic, Inc.

Manufacturer

Lorad, A Hologic, Inc.
  • Adresse du fabricant
    Lorad, A Hologic, Inc., 36 Apple Ridge Rd, Danbury CT 06810-7301
  • Société-mère du fabricant (2017)
    Hologic Inc
  • Source
    USFDA