Device Recall Incu i

  • Model / Serial
    All lots on the market.  model 101
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.
  • Product Description
    Incu i (Atom Infant Incubator Model 101) || Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 || Usage: An incubator for infants.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Atom Medical Corporation, 3-18-15 Hongo, Bunkyo-Ku Japan
  • Manufacturer Parent Company (2017)
  • Source
    USFDA