Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

Recall date

April 25, 2016

Source

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

Recall number

Z-0046-2017

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.

Why it was recalled

It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

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

What was recalled

Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.