FDA-Device2017-02-01Class II
Hitachi Oasis MRI System - C-Spine Coil
Hitachi Medical Systems America Inc
Hazard
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Sold states
USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Affected count
180 units
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Hitachi Oasis MRI System - C-Spine Coil
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2017Don't want to check this manually?
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