FDA-Device2013-06-26Class I
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: 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. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life
Verathon, Inc.
Hazard
Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.
Sold states
Worldwide distribution: USA (nationwide) including states of : AK, AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington DC, Guam, and countries of : Argentina, Australia, Brazil, Canada, China, Ecuador, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Japan, Malaysia, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, The Netherlands, United Kingdom, and Venezuela.
Affected count
4784 units worldwide (3,381 in the US and 1403 international)
Manufactured in
20001 N Creek Pkwy, Bothell, WA, United States
Products
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: 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. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2013Don't want to check this manually?
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