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Sedecal S.A. recalls RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor
Recalled August 26, 2015 · FDA recall Z-2390-2015 · Sedecal S.A
Hazard
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. · FDA Class II
Units
361 systems (U.S.); 5 systems (Foreign)
Sold at
Distributed US (nationwide) and in Canada.
Description
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.
Product
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.
Manufacturer(s)
Sedecal S.A.
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →