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Hitachi Medical Systems America Inc recalls Hitachi Oasis MRI System - C-Spine Coil
Recalled February 1, 2017 · FDA recall Z-1096-2017 · Hitachi Medical Systems America
Hazard
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam. · FDA Class II
Units
180 units
Sold at
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.
Description
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Product
Hitachi Oasis MRI System - C-Spine Coil
Manufacturer(s)
Hitachi Medical Systems America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →