Events

Rappel de Device Recall Merge Unity Z3D software

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
    74846
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2551-2016
  • Date de mise en oeuvre de l'événement
    2015-07-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148592
  • 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
    The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
  • Action
    The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the attached form and return to Merge Healthcare via recall@merge.com. Alternatively, complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than February 22, 2016. Ensure that all users of the product are provided with this notification. If you have further distributed this, identify your customers and notify them at once of this product recall and provide a copy of the recall notification letter. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.

Device

Device Recall Merge Unity Z3D software
  • Modèle / numéro de série
    Version 11.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: CA, PA, TX, and MT.
  • Description du dispositif
    Merge Unity Z3D software. || Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.