Events

Rappel de Device Recall Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0

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, LLC.

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
    57159
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1250-2011
  • Date de mise en oeuvre de l'événement
    2011-01-12
  • Date de publication de l'événement
    2011-02-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95492
  • 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
    Ge healthcare has become aware of safety issues relevant for the xeleris workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. measurements taken on the ct images on the ct system are different from the xeleris workstation 2. inaccurate pet suv values may be calculated when data is retrieved from pacs after being processed in the xeleris. 3. wrong marking of early and late result series on display in bra.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.

Device

Device Recall Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, LUXEMBOURG, LEBANON, MALY ASIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SPAIN, SOUTH AFRICA, SOUTH KOREA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, and VIET NAM.
  • Description du dispositif
    Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 || The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes..
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA