wDR 2 — Class II medical device recall Z-2045-2023
Ongoing recall by SEDECAL SA, reported 2023-07-05, distributed in PR. There is a software login in issue that may prevent the user from logging in.
| Recall number | Z-2045-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, N/A, Spain |
| Recall initiated | 2023-05-23 |
| Classified | 2023-06-30 |
| Reported by FDA | 2023-07-05 |
| Distributed | PR |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CW, CZ, DE, DO, EG, ES, FI, FR, GB, HR, HU, ID, IL, IQ, IR, IT, JO, JP, KE, KW, LB, LT, LU, LV, MT, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, UA, VN, ZA |
| Quantity | 1,061 units |
| Reason classes | software |
| Model numbers | 712002, 712004, 712006, 712007 |
Product
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Reason for recall
There is a software login in issue that may prevent the user from logging in.
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-2045-2023. 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.