Events

Rappel de GE Healthcare Centricity PACS IW

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.

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
    72212
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0023-2016
  • Date de mise en oeuvre de l'événement
    2015-09-16
  • Date de publication de l'événement
    2015-10-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140304
  • 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
    Images may be missing when a system parameter maproute is set to a value greater than 1.
  • Action
    The firm, GE Healthcare, an "Urgent Medical Device Correction" by mail or hand delivered to all sites. The letter instructs the customer to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Until GE Healthcare conducts remote inspection of the systems "MapRoute" parameter value. If the value is found to be greater than the recommended setting of 1, GE will reset this system parameter to a value of 1. The letter informs the user facilities not to make any changes to this parameter value. Additionally, until a product modification is available to correct this issue, the following actions are recommended. The firm is recommending user facilities to: 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the PACS IW viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, contact your GE Healthcare Service representative for assistance and instructions as to the impacted exam. Urgent cases impacted by this issue should be interpreted at the modality. 2. If DICOM storage commit is configured and in use, no commit notification is sent to the modality for images that were impacted by this issue. GE Healthcare will correct all affected systems by providing a software update at no cost to the user facilities. If the user facilities have questions, they are encouraged to communicate questions or concerns regarding this notification to GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Device

GE Healthcare Centricity PACS IW
  • Modèle / numéro de série
    GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, 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, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam¿, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.
  • 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.
  • Manufacturer
    GE Healthcare

Manufacturer

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