Devices

Device Recall REGIUS IM, RIM

  • Modèle / numéro de série
    58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
  • Description du dispositif
    REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
  • Manufacturer
    Konica Minolta Medical Imaging USA, Inc.
  • 1 Event

Fabricant

Konica Minolta Medical Imaging USA, Inc.
  • Adresse du fabricant
    Konica Minolta Medical Imaging USA, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Source
    USFDA