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 | 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. |
| Product | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 |
| Quantity | 851 devices |
| Distribution | US Nationwide distribution. There was government distribution but no military distribution. |
| Initiated | 2021-10-14 |
| Classified | 2024-02-14 |
| Recall number | Z-1083-2024 |
| 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-1083-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93651/
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