FDAMarch 23, 2015device
Sedecal SA Mobile Diagnost w DR x-ray system
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.
What to do
FDA enforcement status: Terminated
Brands named
sedecal
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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