Class II — Swissray Medical
| Recalling firm | Swissray Medical AG |
|---|---|
| Registered facility | SWISSRAY Medical, AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly. |
| Product | ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging |
| Quantity | 27 devices in US |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa. |
| Initiated | 2016-11-18 |
| Classified | 2018-09-18 |
| Recall number | Z-3191-2018 |
| 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 — Swissray Medical (Z-3191-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80981/
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