Events

Recall of Carestream DRX Revolution X-Ray System

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
    17828
  • Event Initiated Date
    2014-12-04
  • 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
    The manufacturer has received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a drx revolution mobile x-ray system as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. no other reports of this type have been received since the device was introduced into commercial distribution in 2009.
  • Action
    Product to be modified

Device

Carestream DRX Revolution X-Ray System

Manufacturer

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