Events

Recall of Device Recall Dual Incu i

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atom Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61807
  • Event Risk Class
    Class 2
  • Event Number
    Z-1945-2012
  • Event Initiated Date
    2012-05-01
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109139
  • Notes / Alerts
    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.
  • Extra notes in the data
    Incubator, neonatal - Product Code FMZ
  • Reason
    There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
  • Action
    Atom Medical sent an Urgent Field Safety Notice dated May 1, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify all affected product in their inventory and quarantine them until the rework was complete. Customers were also asked to identify any customers to whom they further distributed the product and to contact their customers at once and arrange a time in whcih the filed service technician could perform the rework. Customers were asked to return the Recall Response Forms to Atom Medical (kirautc@atomed.co.jp, tsugino@atomed.co.jp, or matsumoto@atomami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.

Device

Device Recall Dual Incu i
  • Model / Serial
    All lots on the market of model 100
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
  • Product Description
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
  • Manufacturer
    Atom Medical Corporation

Manufacturer

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