Events

Field Safety Notices about Kodak 2100 and 2200

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Carestream Health Inc..

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 Number
    SN2014(03)
  • Date
    2014-02-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/kodak-2100-and-2200&id=0679f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The scissor arm bracket on these devices can break which could result in the arm falling.
  • Action
    The IMB recommends that:  1. Examine your devices using the pictures contained in the FSN as reference, and ensure the arm has not failed.  2. If the unit shows early signs of failure at inspection, please stop using it and call your dealer immediately. A service engineer from your dealer will visit to make a detailed inspection and a modification to rectify the problem.  3. Ensure that this IMB safety notice and the attached FSN is passed on to any organisation or end user where the potentially affected devices have been transferred.

Device

Kodak 2100 and 2200

Manufacturer

Carestream Health Inc.
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HPRA