Events

Rappel de Device Recall GE Healthcare Prodigy; Prodigy Advanced

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 Medical Systems Ultrasound & Primary Care Diagnostics, LL.

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
    79710
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1395-2018
  • Date de mise en oeuvre de l'événement
    2018-03-16
  • 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=163129
  • 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
    Densitometer, bone - Product Code KGI
  • Cause
    Under certain conditions, when using dicom worklist along with dicom mpps, a report for a bone density exam may be sent to pacs with the incorrect patient information in the dicom header. the correct patient information will be listed on the dicom report image; however, the report may appear under a different patients name in the pacs.
  • Action
    The firm initiated their recall by letter on March 16, 2018. The notice stated: "Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492

Device

Device Recall GE Healthcare Prodigy; Prodigy Advanced
  • Modèle / numéro de série
    a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365  b) Prodigy Advanced, Model Numbers: LU42361, LU42397
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
  • Description du dispositif
    GE Healthcare: || a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 || b) Prodigy Advanced, Model Numbers: LU42361, LU42397 || Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
  • Manufacturer
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
  • Adresse du fabricant
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, 3030 Ohmeda Dr, Madison WI 53718-6704
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA