FDA-Device2021-03-03Class II
OT1000 Series Orthopedic Surgical Tables
Steris Corporation
Hazard
On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
Sold states
Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.
Affected count
272 tables total (Domestic: 227 tables, Foreign 45 tables)
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
OT1000 Series Orthopedic Surgical Tables
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2021Don't want to check this manually?
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