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

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.

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.