Sedecal S.A. recalls RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or…

Recall date

July 13, 2015

Source

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

Recall number

Z-2390-2015

FDA classification

Class II

Brand / firm

Sedecal S.A.

Sold / distributed

Distributed US (nationwide) and in Canada.

Why it was recalled

Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient.

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

What was recalled

RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.