FDAJuly 18, 2018device
Sedecal NOVA FA DR System. for diagnostic radiography.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
What to do
FDA enforcement status: Ongoing
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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