Field Safety Notices about Kodak 2100 and Kodak 2200 Intraoral X-ray Systems

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by Carestream Health.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Carestream Health, Inc. on the possibility of an earlier damage on the junction of scissors arm holder in intraoral Röntgen systems Kodak 2100 and Kodak 2200.
    The manufacturer has discovered the problem on devices delivered in the time period between May 2008 and April 2010 and advises users to check the devices for damage signs even before visit to service engineers.
    Here you may view the safety information addressed to users.


  • Manufacturer Parent Company (2017)
  • Source