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Sources: EU EUDAMED, US FDA
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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.
FDA Recall
Terminated
·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Recall
Terminated
·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code IZL·January 18, 2016
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Recall
Terminated
·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·August 6, 2014
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA Recall
Open, Classified
·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code MQB·July 18, 2018
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZL·March 23, 2015
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Recall
Open, Classified
·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·August 12, 2022
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_B_D_VIR3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_BDC3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SED URS LP, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025