Events

Field Safety Notices about Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Carestream Health Inc..

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
  • Event Number
    SN2013(08)
  • Date
    2013-07-30
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/trophy-irix-70-irix-708-novelix-6510-and-oramatic-558&id=047bf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The scissor arm bracket on these devices can break which could result in the arm falling.
  • Action
    The IMB recommends that:  1. Relevant personnel in your organisation are made aware of this potential issue.  2. Examine your devices to determine if they are impacted by this issue.  3. Check if your devices have been modified by following the instructions outlined in the attached FSN.  4. For devices that have not been modified, remove them from service and contact Carestream.  5. Ensure that this IMB Safety Notice and the attached FSN is passed on to any organisation or end user where the potentially affected devices have been transferred.

Device

Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558
  • Model / Serial
  • Product Description
    Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558
  • Manufacturer
    Carestream Health Inc.

Manufacturer

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