Events

Rappel de Summit Industries Floor Mounted Tubestand

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 Summit Industries Inc..

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
    69631
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0468-2015
  • Date de mise en oeuvre de l'événement
    2014-10-28
  • Date de publication de l'événement
    2014-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131205
  • 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
    Tube mount, x-ray, diagnostic - Product Code IYB
  • Cause
    The welds on j700 tube stands may be insufficient resulting in tube stand breakage, damage to the x-ray machine, and/or patient or healthcare provider injury.
  • Action
    Summit Industries sent an Urgent Medical Device Recall letter dated October 27, 2014, to all direct accounts (distributors). The letters included instructions for distributors to: 1) make every effort to locate the affected devices; 2) replace and return the defective parts; 3) contact the end user for any defective device(s) that were installed and determine if the affected device(s) is/are in service; 4) if the device(s) is/are still in service, deliver a copy of the "End User Letter", immobilize the tube arm, and place the REMOVE FROM SERVICE sticker on the device; 5) complete and return the attached questionnaire for a no-charge purchase order for the necessary replacement parts; and, 5) inform the end user that new replacement pats will be installed as soon as possible. Distributors with questions can contact Summit Industries at 800-729-9729 (Monday - Friday, 7:00 AM - 3:45 PM CST). The Urgent Medical Device Recall letter dated October 27, 2014, to end users advised them of the recall and the steps that Summit Industries and their distributor would be taking to correct the issue.

Device

Summit Industries Floor Mounted Tubestand
  • Modèle / numéro de série
    Model Numbers: J700-01, J700-02, J700-03, J700-04
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
  • Description du dispositif
    The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
  • Manufacturer
    Summit Industries Inc.

Manufacturer

Summit Industries Inc.
  • Adresse du fabricant
    Summit Industries Inc., 2901 W Lawrence Ave, Chicago IL 60625-3621
  • Source
    USFDA