Events

Rappel de Device Recall Helix

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
    67464
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1200-2014
  • Date de mise en oeuvre de l'événement
    2014-02-07
  • Date de publication de l'événement
    2014-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125672
  • 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, tomography, computed, emission - Product Code KPS
  • Cause
    Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry. n.
  • Action
    GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.

Device

Device Recall Helix
  • Modèle / numéro de série
    all serial numbers are listed in Product 1.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
  • Description du dispositif
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
  • 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