FDAOctober 14, 2021device
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
What to do
FDA enforcement status: Ongoing
Brands named
sedecal sasedecal
UPCs
0088483802858600884838082373084360460021730088483809150408436046002357
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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