Events

Rappel de Merge LIS

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 Merge Healthcare, 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
    77299
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2628-2017
  • Date de mise en oeuvre de l'événement
    2016-04-15
  • Date de publication de l'événement
    2017-05-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155647
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    There are potential issues with results reporting for certain run-based tests. under certain conditions, the wrong results could inadvertently be verified.
  • Action
    Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it is made available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 29, 2016. For further questions, call (877) 741-5369.

Device

Merge LIS
  • Modèle / numéro de série
    Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.
  • Description du dispositif
    Merge LIS software. The firm name on the label is Merge Healthcare. || Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.