Hitachi Medical Systems America Inc recalls Hitachi Oasis MRI System
- Recall date
- April 16, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1540-2017
- FDA classification
- Class II
- Brand / firm
- Hitachi Medical Systems America Inc
- Sold / distributed
- 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) gover…
Why it was recalled
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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
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