Events

Field Safety Notices about Marus Brand LuxStar Dental Lights

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

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
    SN2011(26)
  • Date
    2011-11-16
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/marus-brand-luxstar-dental-lights&id=c381f825-9782-6eee-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
    Marus has become aware that the lens heat (bulb) shield (birdcage) on the marus luxstar dental lights, model ol1000, may potentially fall off the dental light if not properly installed after replacing the light bulb, or if not properly maintained.
  • Action
    Marus has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, Dacus Dental, has ceased trading. The serial numbers of the devices provided to Dacus Dental are 4714B and 165569B.  The IMB advises that users:  • Identify the affected devices in your facility.  • Ensure the appropriate personnel are made aware of this notice.  • If you (or your facility) have affected devices, follow the recommendations outlined in the attached Field Safety Notice and contact Marus to obtain the self-installation kit.

Device

Marus Brand LuxStar Dental Lights
  • Model / Serial
  • Product Description
    Marus Brand LuxStar Dental Lights
  • Manufacturer
    Marus

Manufacturer

Marus