Events

Rappel de DR Systems Unity PACS software, now known as Merge Unity PACS

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
    76541
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1426-2017
  • Date de mise en oeuvre de l'événement
    2016-04-08
  • Date de publication de l'événement
    2017-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153466
  • 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
    Reports were missing demographic header information when they were faxed to referring physicians.
  • Action
    Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016, to all affected customers via email on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is 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 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 8, 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. The recalling firm reported emails will be tracked for delivery confirmation. For further questions please call ( 877) 741-5369.

Device

DR Systems Unity PACS software, now known as Merge Unity PACS
  • Modèle / numéro de série
    Version 11.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
  • Description du dispositif
    DR Systems Unity PACS software, now known as Merge Unity PACS
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.