Events

Avis De Sécurité sur Marus Brand LuxStar Dental Lights

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Marus.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2011(26)
  • Date
    2011-11-16
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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 / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Marus Brand LuxStar Dental Lights
  • Manufacturer
    Marus

Manufacturer

Marus