Events

Rappel de GE Centricity PACS (Versions 3.1.1.2 or later)

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 Ge Healthcare It.

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
    64724
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0731-2014
  • Date de mise en oeuvre de l'événement
    2012-09-15
  • Date de publication de l'événement
    2014-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116867
  • 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
    There is a potential loss of image(s) associated with the centricity to centricity (c2c) exam transfer module of centricity pacs system versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. when another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. once ter.
  • Action
    GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.

Device

GE Centricity PACS (Versions 3.1.1.2 or later)
  • Modèle / numéro de série
    GE Centricity Software versions 3.X and higher and 4.X and higher
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
  • Description du dispositif
    Centricity PACS System versions 3.X and higher and 4.X and higher || Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Adresse du fabricant
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA