FDA-Device2022-02-02Class II
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
GE Healthcare, LLC
Hazard
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Sold states
Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Ecuador, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Haiti, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Papua New Guinea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sweden, Switzerland, Thailand, Togo, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, and Western Sahara.
Affected count
12,526 total reported units (77 units of this model)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2022Don't want to check this manually?
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