Events

Recall of Carestream PACS Client Workstation

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
    15496
  • Event Initiated Date
    2013-10-16
  • 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
    Carestream health has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios. this problem occurs infrequently and only when all of the following conditions are met:, 1) the version installed is v11.3.2 or v11.3.2.4 or v11.4, 2) the exam type is from multi-slice modalities, 3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images., 4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Action
    Software to be upgraded

Device

Carestream PACS Client Workstation
  • Model / Serial
    Model: Catalogue numbers: 1308519, 1530633, 1467067, 1405794, 8171837, Affected: Software Versions: 11.3.2.0 / 11.3.2.4 / 11.4
  • Manufacturer
    Carestream Health Inc

Manufacturer

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