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FDA-Device2021-12-15Class II

OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II R

Osteomed, LLC
Hazard

Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Indonesia, Italy, Japan, Korea, Kuwait, Lithuania, Malaysia, Mexico, Russia, Spain, Thailand, Turkey, United Kingdom, and Venezuela.
Affected count
533 consoles and 586 footswitches
Manufactured in
3885 Arapaho Rd, N/A, Addison, TX, United States
Products
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2022

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