Events

Rappel de Device Recall Merge OrthoPACS

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
    77271
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2601-2017
  • Date de mise en oeuvre de l'événement
    2017-05-24
  • 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=155590
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Studies that have qc, pde, or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
  • Action
    Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). 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 15 calendar days after receipt of the recall letter using the enclosed form. 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 recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.

Device

Device Recall Merge OrthoPACS
  • Modèle / numéro de série
    Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
  • Description du dispositif
    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.