Hitachi Medical Systems America Inc recalls Hitachi Oasis MRI System - C-Spine Coil

Recall date

January 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1096-2017

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

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 acco…

Why it was recalled

The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hitachi Oasis MRI System - C-Spine Coil