Events

Recall of Carestream - Image Suite

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Carestream Health Inc.

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
    20083
  • Event Initiated Date
    2016-04-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • Reason
    A software issue related to image orientation. if the image suite software receives a computed tomography (ct )or magnetic resonance (mr) image with the image orientation (i.Epatient) tag specified and the overlay is configured to display this tag, then the left side is marked r and the right marked l and the anterior marked p and the posterior marked a.
  • Action
    Software to be upgraded

Device

Carestream - Image Suite

Manufacturer

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