Events

Field Safety Notices about DRX-Revolution

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Carestream Health.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-01-13
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Carestream health has identified a defect in the production of the drx-revolution that could cause it to move inadvertently. in our own investigation of the only reported event, we found that the center lever of the drive lever, which had escaped and had an effect on the operation of the drive and brake mechanism, prevented the device from stopping. there were no consequential injuries, but there is a risk that the device may have a life-cycle problem with other units. failure to stop the unit and contact with the person may result in injury.

Device

DRX-Revolution

Manufacturer

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