FDA-Device2015-08-26Class II
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.
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.
Sold states
Distributed US (nationwide) and in Canada.
Affected count
361 systems (U.S.); 5 systems (Foreign)
Manufactured in
C/Pelaya, 9-13, Pol. Industrial Rio De Janiero, Algete, Spain
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2390-2015Don't want to check this manually?
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