SEDECAL SA Recalls

49 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (49)

June 10, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SED URS LP, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SHIMADZU RF.004, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
RADPRO MOBILE, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFX, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SM_40HF_BDC3, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SM_40HF_B_D_VIR3, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KW-FX.899, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
SM_40HF_BDC, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWMOBILE3.899, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class II
January 22, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20H
Potential interference with the anti-fall system.
Class II
December 13, 2023
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying po
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Class II
October 14, 2021
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
Class II

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.