Device Recall Retcam3 & Retcam Shuttle with version

  • Model / Serial
    Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
  • Product Description
    Retcam3 & Retcam Shuttle with version 6.0 software. || Clarity Medical Systems, Inc. || 5775 W. Las Positas Blvd, Suite 200 || Pleasanton, CA 94588 || General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Clarity Medical Systems Inc, 5775 W Las Positas Blvd, Pleasanton CA 94588
  • Manufacturer Parent Company (2017)
  • Source
    USFDA