Events

Rappel de Device Recall Bladeline Cabinet Xray system

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 Inspection Technologies, LP.

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
    77756
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2777-2017
  • Date de mise en oeuvre de l'événement
    2017-06-28
  • 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=157833
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Cause
    Ge inspection technologies, lp determined that the blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliroentgen in one hour (21 cfr ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. the crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
  • Action
    GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.

Device

Device Recall Bladeline Cabinet Xray system
  • Modèle / numéro de série
    Serial No.  TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
  • Description du dispositif
    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
  • Manufacturer
    GE Inspection Technologies, LP

Manufacturer

GE Inspection Technologies, LP
  • Adresse du fabricant
    GE Inspection Technologies, LP, 50 Industrial Park Rd, Lewistown PA 17044-9312
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA