Devices

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.
  • 1 Event

Fabricant

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