Events

Rappel de Device Recall GE Centricity 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 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
    65471
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0116-2014
  • Date de mise en oeuvre de l'événement
    2013-06-11
  • Date de publication de l'événement
    2013-10-30
  • 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=119028
  • 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
    Radiological Image Processing System - Product Code LLZ
  • Cause
    Ge has recently become aware of potential issues due to out of context issues associated with specific workflows of the centricity pacs ra1000 workstation. these issues are as follows: 1) in centricity ris-ic, and a ris-driven integration, the "close" button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation. 2) interrupted workflow could break the.
  • Action
    URGENT MEDICAL DEVICE CORRECTION letters dated June 11, 2013 was mailed to all customers alerting them to these potential safety issues. The software was modified to correct these defects and a GE Healthcare service representative will contact each customer to make arrangements for installation of the new software version at no charge to the customer. Customers with concerns or questions about the market action can contact their local GE Healtchcare IT service representative or GE Healthcare's Remote Online Center - Customer Care Center at 1-800-437-1171.

Device

Device Recall GE Centricity PACS
  • Modèle / numéro de série
    GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia.
  • Description du dispositif
    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