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Sedecal SA FDA Recalls
53 recalls on file across devices, 0 of them Class I and 53 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| SED URS LP, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| SM_40HF_B_D_VIR3.004, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS.004, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| RADPRO MOBILE, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| SM_40HF_BDC, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| SHIMADZU RF.004, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)Class IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWMOBILE3.899, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| SM_40HF_BDC3, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS.005, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KW-FX.899, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS-710CW, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS.002, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFX, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS-710CW.007, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| SM_40HF_B_D_VIR3, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number 40KWFXPLUS.889, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemClass IIJun 10, 2025Sedecal sent an email to its consignees to remind the users |
| Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HFClass IIJan 22, 2024Potential interference with the anti-fall system. |
| Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.Class IIDec 13, 2023Some parts have fallen off the equipment resulting in a safe |
| wDR 2.2 Mobile Digital Diagnostic X-Ray SystemClass IIMay 23, 2023There is a software login in issue that may prevent the user |
| Phoenix mKDR Xpress, digital mobile diagnostic x-ray systemClass IIFeb 6, 2023Sedecal was informed of 3 incidents of erratic movements rel |
| Phoenix mKDR, digital mobile diagnostic x-ray systemClass IIFeb 6, 2023Sedecal was informed of 3 incidents of erratic movements rel |
| Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500Class IIAug 12, 2022Due to un-commanded movement of mobile x-ray unit. |
| MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007Class IIOct 14, 2021While cleaning or disinfecting the system, if the process is |