FDA-Device2013-08-14Class II
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Radiometer America Inc
Hazard
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
Sold states
Worldwide distribution: US (nationwide) AK, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.
Affected count
5,874 units
Manufactured in
810 Sharon Dr, N/A, Westlake, OH, United States
Products
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2013Don't want to check this manually?
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