FDA-Device2020-12-16Class II
MAC VU360, Electrocardiograph
GE Healthcare, LLC
Hazard
Incorrect patient identification and/or patient demographic errors.
Sold states
Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom.
Affected count
5,284 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
MAC VU360, Electrocardiograph
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2021Don't want to check this manually?
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