Portable X-ray system — Class II medical device recall Z-2117-2025
Ongoing recall by DIGIMED CO., LTD, reported 2025-07-30. Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm
| Recall number | Z-2117-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | DIGIMED CO., LTD, Seoul, N/A, Korea (the Republic of) |
| Recall initiated | 2025-06-19 |
| Classified | 2025-07-18 |
| Reported by FDA | 2025-07-30 |
| Quantity | 530 |
| UPC / GTIN / UDI-DI | 08800021800014 |
Product
Portable X-ray system
Reason for recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
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-2117-2025. 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.