FDAJune 10, 2025device
Model Number 40KWFXPLUS, Mobile X-ray system
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
sedecal sasedecal
UPCs
08436046002166
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAModel Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system2025-06-10
- FDAModel Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system2025-06-10
- FDAMobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system2025-06-10
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