FDA-Device2021-10-06Class II
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Deerfield Imaging, Inc.
Hazard
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Sold states
Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Affected count
10 units
Manufactured in
5101 Shady Oak Rd S, N/A, Minnetonka, MN, United States
Products
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2585-2021Don't want to check this manually?
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