MobileDiagnost wDR — Class II medical device recall Z-1083-2024
Ongoing recall by SEDECAL SA, reported 2024-02-21, distributed nationwide. While cleaning or disinfecting the system, if the process is not followed as described in the manual and exces
| Recall number | Z-1083-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, N/A, Spain |
| Recall initiated | 2021-10-14 |
| Classified | 2024-02-14 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 851 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838028586, 00884838082373, 00884838091504, 08436046002173, 08436046002357 |
| Serial numbers | 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071 and 136 more |
| Model numbers | 712001, 712002, 712004, 712006, 712007 |
Product
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Reason for recall
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.
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-1083-2024. 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.