GE Healthcare, LLC recalls Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for g…

Recall date

November 15, 2018

Source

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

Recall number

Z-0693-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austria,…

Why it was recalled

Possible incorrect software version loaded.

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

What was recalled

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use