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Hitachi Medical Systems America Inc recalls Hitachi Oasis MRI System
Recalled March 29, 2017 · FDA recall Z-1540-2017 · Hitachi Medical Systems America
Hazard
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. · FDA Class II
Units
210 units
Sold at
US nationwide distribution. The products were 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, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902. There are zero (0) Canada accounts for this recall. There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170 The product was distributed to the following countries: Brazil.
Description
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Product
Hitachi Oasis MRI System
Manufacturer(s)
Hitachi Medical Systems America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →