Rappel de Device Recall Responder 5

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Rauland-Borg Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65657
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2213-2013
  • Date de mise en oeuvre de l'événement
    2013-05-10
  • Date de publication de l'événement
    2013-09-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2015-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, communication, powered - Product Code ILQ
  • Cause
    A counterfeited electronic component was identified in the products affected. the component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the responder 5 system across the l-net data path. failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the l-net run.
  • Action
    Tech Bulletins sent a letter dated May 10, 2013, to all affected customers notifying them of the counterfeit parts and requesting that customers uninstall and return affected products to Rauland-Borg for replacement. A subsequent recall notification letter dated August 5, 2013 was mailed to customers. The letter included instructions to both direct accounts and end users on the process of replacing affected units with units manufactured with authentic parts. For additional information please call 847-590-5920.

Device

  • Modèle / numéro de série
    1) Product Code 351000 (Branch Regional Controller);  2) Product Code 352000 (Corridor Light);  3) Product Code 352020 (Domeless Controller)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.
  • Description du dispositif
    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. || Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Rauland-Borg Corp, 1802 W Central Rd, Mount Prospect IL 60056-2230
  • Société-mère du fabricant (2017)
  • Source
    USFDA