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
    18563
  • Event Initiated Date
    2015-05-22
  • 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
    Images successfully transmitted to intelepacs may not be available for reading in all studies. this failure can be detected if the client has image count verification protocols. this failure can also be detected if complete series are missing as the user will know to look for those missing series. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy, which is also highly detectable. however, under certain circumstances it can appear as if the study is complete with no user observable means to identify the failure. no patient incident has been reported to date.
  • Action
    Software to be upgraded

Device

Intelerad InteleradPACS
  • Model / Serial
    Model: , Affected: Software versions: 4.7.1 R27 and up, 4.8.1 R20 and up, 4.9.1 R17 and up, 4.10.1 R9 and up, 4.11.1 R3 and up
  • Manufacturer
    Intelerad Medical Systems Incorporated

Manufacturer

Intelerad Medical Systems Incorporated