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IMRIS Inc recalls IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedure
Recalled November 5, 2014 · FDA recall Z-0144-2015 · IMRIS
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. · FDA Class II
Units
14
Sold at
Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
Description
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.
Product
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Manufacturer(s)
IMRIS Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →