Class II — DIGIMED CO., LTD
| Recalling firm | DIGIMED |
|---|---|
| Registered facility | DIGIMED CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
| Product | Portable X-ray system |
| Quantity | 530 |
| Distribution | US |
| Initiated | 2025-06-19 |
| Classified | 2025-07-18 |
| Recall number | Z-2117-2025 |
| Initiation | FDA Mandated |
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 — DIGIMED CO., LTD (Z-2117-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97270/
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