Swissray Medical recalls ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Recall date

November 18, 2016

Source

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

Recall number

Z-3191-2018

FDA classification

Class II

Brand / firm

Swissray Medical

Sold / distributed

Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.

Why it was recalled

Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

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

What was recalled

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging