Class II — SEDECAL SA
| Recalling firm | SEDECAL S.A. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to un-commanded movement of mobile x-ray unit. |
| Product | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 |
| Quantity | 155 systems |
| Distribution | U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A |
| Initiated | 2022-08-12 |
| Classified | 2022-11-04 |
| Recall number | Z-0182-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SEDECAL SA (Z-0182-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90736/
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