FDA recall Z-2172-2021

Verathon, Inc. · Class III · device

Product

GlideScope Go Monitors

Reason for recall

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, RI, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Australia, Brunei Darussalam, Canada, Czech Republic, Denmark, Estonia, Falkland Island (Malvinas), France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Kuwait, Luxembourg, Malaysia, New Zealand, Oman, Papua New Guinea, Philippines, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Arab Emerita, and United Kingdom.

Key facts

Status
Ongoing
Initiation date
2021-07-01
Report date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2172-2021