Events

Field Safety Notices about Cervical Halo Traction Apparatus

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

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
    SN2004(02)
  • Date
    2004-03-12
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/cervical-halo-traction-apparatus&id=8895f825-9782-6eee-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 potential for imaging problems ranging from artifact, sparking, vibration, patient discomfort and / or surface burns when the cervical halo device is worn during a mri scan.
  • Action
    Ensure that all devices that are sold as single use devices are only use once Ensure that MRI compatible devices are configured and positioned in the MRI so as to ensure that they are not too close to the MRI core and that metal components are not  criss-crossing or concentrated in one area  Ensure that the use of all MRI compatible devices are reviewed when any changes are made to the MRI strength to ensure that they still remain compatible  Ensure that patients screening forms are completed for all patients. (see form attached checklist) Report any indications of problems to the IMB

Device

Cervical Halo Traction Apparatus
  • Model / Serial
  • Product Description
    Cervical Halo Traction Apparatus
  • Manufacturer
    Jerome Medical

Manufacturer

Jerome Medical
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    HPRA