Reported Aug 26, 2015 · Terminated
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or…
Sedecal S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sedecal S.A. · C/Pelaya, 9-13 · Algete · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
366 of 366 codes
G29393G29395G29404G29416G29426G29864G29873G29878G30025G30155G30156G30160G30165G30173G30236G30240G30250G30254G30258G30567G30570G30684G30689G30761G30762G30771G30808G30902G30952G30960G31065G31077G31252G31256G31259G31271G31285G31403G31412G31526G31761G32487G32498G32514G32577G32581G32584G32587G32657G32671G32753G32936G33004G33102G33103G33111G33112G33126G33127G33144
- Serial numbers
- Amount recalled
- 361 systems (U.S.); 5 systems (Foreign)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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