SEDECAL SA Recalls
53 recalls on record · November 16, 2022 to October 29, 2025 · Medical Devices
Recalls by year
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWMOBILE3.899, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.889, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.005, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.004, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.002, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KW-FX.899, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFX, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Hazard: 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.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Hazard: 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.
May 8, 2024Medical DevicesFDA
SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF
Hazard: Potential interference with the anti-fall system.
February 21, 2024Medical DevicesFDA
SEDECAL SA recalls MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Hazard: 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.
January 31, 2024Medical DevicesFDA
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.
Hazard: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
July 5, 2023Medical DevicesFDA
SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
Hazard: There is a software login in issue that may prevent the user from logging in.
March 8, 2023Medical DevicesFDA
SEDECAL SA recalls Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Hazard: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
March 8, 2023Medical DevicesFDA
SEDECAL SA recalls Phoenix mKDR, digital mobile diagnostic x-ray system
Hazard: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
November 16, 2022Medical DevicesFDA
SEDECAL SA recalls Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Hazard: Due to un-commanded movement of mobile x-ray unit.