SEDECAL SA
SEDECAL SA appears in FDA public data with 57 recalls, 26 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0279-2026, Class II) was initiated on June 10, 2025. Its most recent 510(k) clearance was granted on August 21, 2023.
Summary
- Total Recalls
- 57
- 510(k) Clearances
- 26
- Inspections
- 3
- Compliance Actions
- 0
Known Names
sedecal, sedecal usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0279-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system | June 10, 2025 |
| Z-0260-2026 | Class II | Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system | June 10, 2025 |
| Z-0276-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system | June 10, 2025 |
| Z-0267-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system | June 10, 2025 |
| Z-0274-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system | June 10, 2025 |
| Z-0287-2026 | Class II | SM_40HF_BDC3, Mobile X-ray system | June 10, 2025 |
| Z-0244-2026 | Class II | Model Number 40KWFX, Mobile X-ray system | June 10, 2025 |
| Z-0266-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | June 10, 2025 |
| Z-0286-2026 | Class II | SM_40HF_BDC, Mobile X-ray system | June 10, 2025 |
| Z-0282-2026 | Class II | SED URS LP, Mobile X-ray system | June 10, 2025 |
| Z-0268-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system | June 10, 2025 |
| Z-0251-2026 | Class II | Model Number 40KWFXPLUS-710CW, Mobile X-ray system | June 10, 2025 |
| Z-0278-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system | June 10, 2025 |
| Z-0248-2026 | Class II | Model Number 40KWFXPLUS.004, Mobile X-ray system | June 10, 2025 |
| Z-0281-2026 | Class II | RADPRO MOBILE, Mobile X-ray system | June 10, 2025 |
| Z-0249-2026 | Class II | Model Number 40KWFXPLUS.005, Mobile X-ray system | June 10, 2025 |
| Z-0256-2026 | Class II | Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system | June 10, 2025 |
| Z-0273-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system | June 10, 2025 |
| Z-0264-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system | June 10, 2025 |
| Z-0269-2026 | Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system | June 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K232185 | SM-IV | August 21, 2023 |
| K222951 | SM-V | November 21, 2022 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | July 18, 2022 |
| K212291 | PHOENIX | September 14, 2021 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | February 1, 2021 |
| K202293 | Radiographic System Challenge X | October 7, 2020 |
| K192936 | Soltus 500 | November 15, 2019 |
| K192011 | PhoeniX | September 25, 2019 |
| K191813 | MobileDiagnost wDR 2.2 | August 2, 2019 |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | January 26, 2018 |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | July 6, 2016 |
| K141895 | MOBILEDIAGNOST WDR | September 18, 2014 |
| K133782 | NOVA FA DR SYSTEM | March 21, 2014 |
| K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | April 18, 2013 |
| K121410 | DRAGON LW | August 2, 2012 |
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | August 5, 2011 |
| K111725 | MOBILEDIAGNOST WDR | July 19, 2011 |
| K103522 | SEDECAL | January 26, 2011 |
| K090322 | EASY MOVING PLUS, SM-XXHF-YY | March 17, 2009 |
| K090279 | SEDECAL, MILLENNIUM PLUS | March 11, 2009 |