Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery… — Class II medical device recall Z-0182-2023
Ongoing recall by SEDECAL SA, reported 2022-11-16, distributed in AL, AR, AZ, CA, DE, FL, GA, HI…. Due to un-commanded movement of mobile x-ray unit.
| Recall number | Z-0182-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, N/A, Spain |
| Recall initiated | 2022-08-12 |
| Classified | 2022-11-04 |
| Reported by FDA | 2022-11-16 |
| Distributed | AL, AR, AZ, CA, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, MT, NC, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Quantity | 155 systems |
| UPC / GTIN / UDI-DI | 08436046002432, 08436046002449, 08436046002456, 08436046002463, 08436046002531, 08436046002548, 08436046002555, 08436046002562 |
Product
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Reason for recall
Due to un-commanded movement of mobile x-ray unit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0182-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.