FDA-Device2014-11-05Class II
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
IMRIS Inc
Hazard
One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
Sold states
Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
Affected count
14
Manufactured in
5101 Shady Oak Rd S, N/A, Hopkins, MN, United States
Products
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0144-2015Don't want to check this manually?
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