SEDECAL SA
FDA Regulatory Profile
SEDECAL SA has 57 FDA recalls, 3 inspections, 26 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0276-2026 · Class II · Jun 10, 2025
- Latest inspection
- Jan 24, 2025 · OAI
- Latest 510(k)
- Aug 21, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 57 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 26 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0276-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system | Jun 10, 2025 |
| Z-0284-2026 | Class II | SM_40HF_B_D_VIR3, Mobile X-ray system | Jun 10, 2025 |
| Z-0265-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system | Jun 10, 2025 |
| Z-0282-2026 | Class II | SED URS LP, Mobile X-ray system | Jun 10, 2025 |
| Z-0280-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system | Jun 10, 2025 |
| Z-0283-2026 | Class II | SHIMADZU RF.004, Mobile X-ray system | Jun 10, 2025 |
| Z-0268-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system | Jun 10, 2025 |
| Z-0258-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system | Jun 10, 2025 |
| Z-0246-2026 | Class II | Model Number 40KWFXPLUS, Mobile X-ray system | Jun 10, 2025 |
| Z-0244-2026 | Class II | Model Number 40KWFX, Mobile X-ray system | Jun 10, 2025 |
| Z-0270-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | Jun 10, 2025 |
| Z-0277-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system | Jun 10, 2025 |
| Z-0257-2026 | Class II | Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system | Jun 10, 2025 |
| Z-0250-2026 | Class II | Model Number 40KWFXPLUS.889, Mobile X-ray system | Jun 10, 2025 |
| Z-0251-2026 | Class II | Model Number 40KWFXPLUS-710CW, Mobile X-ray system | Jun 10, 2025 |
| Z-0278-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system | Jun 10, 2025 |
| Z-0267-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system | Jun 10, 2025 |
| Z-0272-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system | Jun 10, 2025 |
| Z-0249-2026 | Class II | Model Number 40KWFXPLUS.005, Mobile X-ray system | Jun 10, 2025 |
| Z-0260-2026 | Class II | Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system | Jun 10, 2025 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3002495042 | Algete, Spain | 3 | Jan 24, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232185 | SM-IV | Aug 21, 2023 |
| K222951 | SM-V | Nov 21, 2022 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Jul 18, 2022 |
| K212291 | PHOENIX | Sep 14, 2021 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | Feb 1, 2021 |
| K202293 | Radiographic System Challenge X | Oct 7, 2020 |
| K192936 | Soltus 500 | Nov 15, 2019 |
| K192011 | PhoeniX | Sep 25, 2019 |
| K191813 | MobileDiagnost wDR 2.2 | Aug 2, 2019 |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Jan 26, 2018 |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Jul 6, 2016 |
| K141895 | MOBILEDIAGNOST WDR | Sep 18, 2014 |
| K133782 | NOVA FA DR SYSTEM | Mar 21, 2014 |
| K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | Apr 18, 2013 |
| K121410 | DRAGON LW | Aug 2, 2012 |
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | Aug 5, 2011 |
| K111725 | MOBILEDIAGNOST WDR | Jul 19, 2011 |
| K103522 | SEDECAL | Jan 26, 2011 |
| K090322 | EASY MOVING PLUS, SM-XXHF-YY | Mar 17, 2009 |
| K090279 | SEDECAL, MILLENNIUM PLUS | Mar 11, 2009 |