Events

Recall of Kodak Flexible ERLM (Light Memory Radio Screen)

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Kodak.

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
  • Date
    2005-04-15
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-ecrans-erlm-flexibles-pour-systeme-de-numerisation-kodak-direct-view-cr500
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    Kodak is in the process of removing and replacing the product references and codes (listed in the Appendix) of the medical device known as Kodak Flexible ERLM (Light Memory Radio Screen) because of a potential for artifacts that may appear on the images. The company has directly notified the recipients concerned by means of the attached message (15/04/2005) (15 KB) validated by Afssaps. The competent European authorities concerned will be informed of this measure by the competent authority. British.

Device

Kodak Flexible ERLM (Light Memory Radio Screen)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Kodak

Manufacturer

Kodak
  • Source
    LAANSM