Class II — SEDECAL SA
| Recalling firm | SEDECAL S.A. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. |
| Product | Phoenix mKDR, digital mobile diagnostic x-ray system |
| Quantity | 53 units |
| Distribution | US, Argentina, Panama |
| Initiated | 2023-02-06 |
| Classified | 2023-03-02 |
| Recall number | Z-1202-2023 |
| Initiation | Voluntary: Firm initiated |
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 — SEDECAL SA (Z-1202-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91656/
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