Events

Rappel de Merge Cardio

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
    76401
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1415-2017
  • Date de mise en oeuvre de l'événement
    2016-04-04
  • Date de publication de l'événement
    2017-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153076
  • 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
    A situation can occur allowing two physicians to access the same study report in echoims when launched from the cardio study list without receiving the read-only notification prompt.
  • Action
    Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail on April 4, 2016. A letter was issued to nonresponders on July 11, 2016. The letter notifies the customer of the issue, informs them of the workaround, and that no further action was being taken to correct the issue, therefore, the customer needs to be aware of the possible behavior. 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 understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. For further information please call (877) 741-5369.

Device

Merge Cardio
  • Modèle / numéro de série
    Version 9.0.9 and earlier using EchoIMS.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
  • Description du dispositif
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.