Events

Rappel de Device Recall RadSuite

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
    74924
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2685-2016
  • Date de mise en oeuvre de l'événement
    2016-01-30
  • 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=148881
  • 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
    Interventional radiology (ir) images are stored as jpeg2k lossless in merge enterprise archive (ea) and are not displaying correctly in radsuite.
  • Action
    The firm, Merge, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 1/29/2016 and 5/25/2016 via e-mail or via certified mail if they did not have an e-mail address for the customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: you must discontinue using the affected version of RadSuite or iConnect Enterprise Archive with GE AW Workstation; use the workaround listed in the letter; complete and return the enclosed form no later than June 17, 2016; ensure that all users of the product are provided with the notification; if you have further distributed this product, please identify your customers and notify them at once of this product recall Merge has a released fix available for this issue. If you have any additional questions, please send an email to recall@merge.com or call 800-724-5970 ext 8027.

Device

Device Recall RadSuite
  • Modèle / numéro de série
    Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: CO and OK.
  • Description du dispositif
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. || RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.