GE Healthcare, LLC recalls System, Tomography Computed Emmission

Recall date

November 30, 2018

Source

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

Recall number

Z-2259-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, Indi…

Why it was recalled

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

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

What was recalled

System, Tomography Computed Emmission