Events

Recall of Intelerad InteleradPACS

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Intelerad Medical Systems Incorporated.

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
    18974
  • Event Initiated Date
    2015-08-20
  • 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: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
  • Reason
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred., the user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • Action
    Software to be upgraded

Device

Intelerad InteleradPACS
  • Model / Serial
    Model: , Affected: Software version contains a "P" (eg PACS 4.5.1 P123) or contains an "R" with the following: PACS-4-5-1-R70, PACS-4-6-1-R80, PACS-4-8-1-R40, PACS-4-9-1-R30, PACS-4-10-1-R30, PACS-4-11-1-R20, Software version: Versions 4.5.1 to 4.11.1
  • Manufacturer
    Intelerad Medical Systems Incorporated

Manufacturer

Intelerad Medical Systems Incorporated