Events

Rappel de Device Recall Ascom Mobile Monitoring Gateway

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 Ascom US, INC..

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
    73578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1638-2016
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144525
  • 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,network and communication,physiological monitors - Product Code MSX
  • Cause
    Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. messages from ge carescape/nurse call will not forward to handset until primary module is restored.
  • Action
    On January 4, 2016 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 2016, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.

Device

Device Recall Ascom Mobile Monitoring Gateway
  • Modèle / numéro de série
    Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
  • Description du dispositif
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
  • Manufacturer
    Ascom US, INC.

Manufacturer

Ascom US, INC.
  • Adresse du fabricant
    Ascom US, INC., 300 Perimeter Park Dr Ste D, Morrisville NC 27560-9703
  • Source
    USFDA