Events

Rappel de The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5

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 Verathon, 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
    63635
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0478-2013
  • Date de mise en oeuvre de l'événement
    2012-10-25
  • Date de publication de l'événement
    2012-12-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114394
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Cause
    Re-usable video laryngoscope blades of the glidescope gvl3, gvl4, and gvl5 were recalled due to potential cracking.
  • Action
    The firm, Verathon, sent an "URGENT - Medical Device Recall" letter dated October 25, 2012, to their consignees/cutomers. The letter described the product, problem, and actions to be taken. The customers were instructed to return the recalled blades back to Verathon and complete and return the Device Recall Notification Reply Form via fax to (425) 883-2896 or email: cservice@verathon.com. All returned products will be quarantined and will be destroyed later. Verathon will replace the affected video laryngoscope blade at no cost to customers. Customers in Canada and US with questions can call 800-331-2313. If you are located outside of the US or Canada, please call 425-867-1348.

Device

The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5
  • Modèle / numéro de série
    Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.
  • Description du dispositif
    The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. || The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. || The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA