Class II — Orthoscan, Inc.
| Recalling firm | Ziehm-Orthoscan INC. |
|---|---|
| Registered facility | ORTHOSCAN, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. |
| Product | Ziehm Solo. Digital Mobile C-arm |
| Quantity | 28 |
| Distribution | U.S. (including Puerto Rico). |
| Initiated | 2024-08-08 |
| Classified | 2024-12-02 |
| Recall number | Z-0573-2025 |
| 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 — Orthoscan, Inc. (Z-0573-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95709/
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