Brainlab AG recalls AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomogr…

Recall date

July 28, 2017

Source

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

Recall number

Z-0509-2018

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan,…

Why it was recalled

Risk of unintended motion while the AIRO system is in transport mode.

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

What was recalled

AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).