Events

Rappel de Device Recall Centricity PACSIW with Universal Viewer

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
    80159
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2101-2018
  • Date de mise en oeuvre de l'événement
    2018-01-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164714
  • 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
    Potential that one or more image series may be missing from an exam without a user warning displayed in the viewer.
  • Action
    On January 28, 2019 GE healthcare notified their customers and gave the following instructions for the Centricity Universal Viewer with PACS-IW foundation 6.0.x; GTIN 00840682103800 and Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation.; Until a product modification is available to correct this issue, the following actions are recommended. 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 Universal Viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, a GE Healthcare Service representative will need to be contacted to assist with resolution of 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. 3. Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue. For historical data inquiries, please contact GE service for assistance in identifying any affected images. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Centricity PACSIW with Universal Viewer
  • Modèle / numéro de série
    102747-1-Centricity Universal Viewer-00558673, 11580-1-Centricity Universal Viewer-00558646, 12945-1-Centricity Universal Viewer-00558658, 103852-1-Centricity Universal Viewer-00116028, 103246-1-Centricity Universal Viewer-00558668, 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 101725-2-Centricity Universal Viewer-00558642,  10227-1-Centricity Universal Viewer-00558665, 9768-1-Centricity Universal Viewer-00558661, 100019-1-Centricity Universal Viewer-00558666, 4284-1-Centricity Universal Viewer-00558672, 101272-1-Centricity Universal Viewer-00558671, 100862-1-Centricity Universal Viewer-01444483, 10278-1-Centricity Universal Viewer-00558655, 9789-1-Centricity Universal Viewer-00558645,  12914-1-Centricity Universal Viewer-00558660, 1696-1-Centricity Universal Viewer-00558659, 4408-1-Centricity Universal Viewer-00558664, 4410-1-Centricity Universal Viewer-00558656, 4407-1-Centricity Universal Viewer-00558657, 4407-1-Centricity Universal Viewer-00558652, 4405-1-Centricity Universal Viewer-00558662, 4546-1-Centricity Universal Viewer-00558670,  100064-1-Centricity Universal Viewer-00558572, 100092-1-Centricity Universal ,Viewer-00558648, 1345-1-Centricity Universal Viewer-00558654,  4705-1-Centricity Universal Viewer-00558663, 4418-1-Centricity Universal Viewer-00558674, 102062-1-Centricity Universal Viewer-00558650, 12866-1-Centricity Universal Viewer-01448215, 101931-1-Centricity Universal Viewer-00558569, 4601-1-Centricity Universal Viewer-00558710, 102406-2-Centricity Universal Viewer-00558669, 102406-2-Centricity Universal Viewer-00558667 A59927-Centricity Universal Viewer-00040382, X13479-Centricity Universal Viewer-00043936, and 269338-Centricity Universal Viewer-01453050, 94767-Centricity Universal Viewer-01422997.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay
  • Description du dispositif
    Centricity PACS-IW with Universal Viewer || Product Usage: || Usage: || Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Adresse du fabricant
    GE Healthcare, 500 W Monroe St, Chicago IL 60661-3671
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA