Events

Rappel de Device Recall Surgical Headlight

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 Gulf Medical Fiberoptics, 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
    58983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0831-2012
  • Date de mise en oeuvre de l'événement
    2011-05-13
  • Date de publication de l'événement
    2012-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100769
  • 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
    Light, surgical, fiberoptic - Product Code FST
  • Cause
    Gulf medical fiberoptics, inc. recalled their surgical headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
  • Action
    On May 16, 2011, Gulf Medical Fiberoptics, Inc. issued to all customers an updated letter to their May 13, 2011 "Field Correction of Instructions For Use" informing them to discontinue the use of 70% isopropyl to clean the surfaces of the device. Enclosed with the letter was an updated Surgical Headlight User Guide with instructions to discard/shred/recycle the prior guide. The firm asked customers to return a form acknowledging the receipt and action from the letter. Customers with questions should contact Customer Service department manager Jacqueline Armand at 813-855-6618 ext. 427.

Device

Device Recall Surgical Headlight
  • Modèle / numéro de série
    Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, GMF-H106.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of FL, WI, WA, AL, CA, MO, MI, OH, VA, CO, TX, TN, NC and the countries of Turkey, Brazil, Belgium, South Korea, Panama, Mexico, Ireland, Taiwan (ROC), Italy, Argentina, India, Spain, Germany, and Venezuela.
  • Description du dispositif
    Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
  • Manufacturer
    Gulf Medical Fiberoptics, Inc.

Manufacturer

Gulf Medical Fiberoptics, Inc.
  • Adresse du fabricant
    Gulf Medical Fiberoptics, Inc., 448 Commerce Blvd., Oldsmar FL 34677
  • Société-mère du fabricant (2017)
    Gulf Medical Fiberoptics, Inc.
  • Source
    USFDA