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
    59767
  • Event Risk Class
    Class 2
  • Event Number
    Z-0337-2012
  • Event Initiated Date
    2011-08-23
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103613
  • 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
    The caster with lock on the incubator or infant warmer may become loose or break.
  • Action
    The firm, Atom Medical, sent an "Urgent: Field Safety Notice" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.

Device

Device Recall Dual Incu i
  • Model / Serial
    All lots on the market.  model 100
  • Product Classification
    General Hospital and Personal Use Devices
  • 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
    Dual Incu i (Atom Infant Incubator Model 100) || Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 || Usage: A combination incubator and warmer 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