Ziehm Imaging Inc recalls Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Recall date

April 15, 2016

Source

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

Recall number

Z-2639-2016

FDA classification

Class II

Brand / firm

Ziehm Imaging Inc

Sold / distributed

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

Why it was recalled

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

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

What was recalled

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging