Events

Recall of The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63635
  • Event Risk Class
    Class 1
  • Event Number
    Z-0478-2013
  • Event Initiated Date
    2012-10-25
  • Event Date Posted
    2012-12-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114394
  • Notes / Alerts
    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.
  • Extra notes in the data
    Laryngoscope, rigid - Product Code CCW
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA