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 | There is a software login in issue that may prevent the user from logging in. |
| Product | wDR 2.2 Mobile Digital Diagnostic X-Ray System |
| Quantity | 1061 units |
| Distribution | Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakh… |
| Initiated | 2023-05-23 |
| Classified | 2023-06-30 |
| Recall number | Z-2045-2023 |
| 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-2045-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92464/
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