FDA recall record · openFDA
SEDECAL SA
51 FDA recalls on record (2023–2025) — 51 device. 51 still ongoing.
0
Class I (most serious)
51
Class II
0
Class III
51
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleane 46
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. 2
Potential interference with the anti-fall system. 1
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. 1
There is a software login in issue that may prevent the user from logging in. 1
Recalls
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Class II 2025-06-10 Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS.004, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system Class II 2025-06-10 SM_40HF_B_D_VIR3, Mobile X-ray system Class II 2025-06-10 SM_40HF_BDC3, Mobile X-ray system Class II 2025-06-10 Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system Class II 2025-06-10 SHIMADZU RF.004, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system Class II 2025-06-10 Model Number 40KW-FX.899, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system Class II 2025-06-10 Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system Class II 2025-06-10 SM_40HF_B_D_VIR3.004, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS.889, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system Class II 2025-06-10 SM_40HF_BDC, Mobile X-ray system Class II 2025-06-10 RADPRO MOBILE, Mobile X-ray system Class II 2025-06-10 Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) Class II 2025-06-10 Model Number 40KWMOBILE3.899, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS.005, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS.002, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system Class II 2025-06-10 Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Class II 2025-06-10 Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS-710CW, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system Class II 2025-06-10 SED URS LP, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFXPLUS, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system Class II 2025-06-10 Model Number 40KWFX, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system Class II 2025-06-10 Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system Class II 2025-06-10 Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system Class II 2025-06-10 Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF Class II 2024-01-22 Phoenix mKDR Xpress, digital mobile diagnostic x-ray system Class II 2023-02-06 Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. Class II 2023-12-13 Phoenix mKDR, digital mobile diagnostic x-ray system Class II 2023-02-06 wDR 2.2 Mobile Digital Diagnostic X-Ray System Class II 2023-05-23
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.