FDAJanuary 18, 2016device
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.
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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