Events

Rappel de Device Recall GE Centricity PACSIW

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
    64730
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0118-2014
  • Date de mise en oeuvre de l'événement
    2012-06-15
  • 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=116875
  • 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
    Multiple issues were identified with the ge centricity pacs-iw system that could pose a safety risk to patients. these issues include: 1) with auto-fetch in use another patient's image may appear without user's intention. 2.A) in the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe.
  • Action
    GE Healthcare sent an IMPORTANT PRODUCT INFORMATION letter dated June 15, 2012 to direct accounts informing them of the Auto-Fetch functionality issue and advising them to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171. GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers informing them of all three of the safety issues. The letter again adivsed customers to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. The letter further infomed customers that all three errors can be resolved through the installation of a new version of the software. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171.

Device

Device Recall GE Centricity PACSIW
  • Modèle / numéro de série
    Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User**
  • Description du dispositif
    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
  • 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