Shimadzu Medical Systems recalls MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Recall date

January 10, 2022

Source

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

Recall number

Z-0867-2022

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A

Why it was recalled

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

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

What was recalled

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1