173 results
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39ms
·
Sources: EU EUDAMED, US FDA
CANON MEDICAL PORTABLE X-RAY MACHINE
FDA Adverse Event
Malfunction
·SEDECAL S. A.·Product code IZL·November 29, 2021
SEDECAL
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZL·February 8, 2010
KONICA MINOLTA
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZO·March 21, 2023
PHILIPS
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZL·October 19, 2018
GE
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code KPR·September 11, 2020
XPLORER 1600 WITH SEDECAL X PLUS LP STAND
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code KPR·November 27, 2006
KONICA MINOLTA
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZO·March 27, 2023
SEDECAL
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZL·March 14, 2016
SEDECAL, MADE FOR: PHILIPS
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IZL·September 21, 2012
MOBILEDIAGNOST WDR
FDA Adverse Event
Injury
·SEDECAL SA·Product code IZL·December 4, 2013
SEDECAL
FDA Adverse Event
Malfunction
·SEDECAL SA·Product code IYB·June 25, 2018
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Enforcement
Class II
·Terminated·Sedecal USA, Inc.·June 15, 2016
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.002, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
RADPRO MOBILE, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025