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Innovative Magnetic Resonance Imaging Systems Inc. recalls IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Ne
Recalled November 28, 2012 · FDA recall Z-0428-2013 · Innovative Magnetic Resonance Imaging Systems
Hazard
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table. · FDA Class II
Units
23
Sold at
Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Description
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Product
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Manufacturer(s)
Innovative Magnetic Resonance Imaging Systems Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →