Class II — Swissray Medical AG
| Recalling firm | Swissray Medical AG |
|---|---|
| Registered facility | SWISSRAY Medical, AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured. |
| Product | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging. |
| Quantity | 3 |
| Distribution | Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru. |
| Initiated | 2018-11-14 |
| Classified | 2019-01-08 |
| Terminated | 2021-09-01 |
| Recall number | Z-0697-2019 |
| 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 AG (Z-0697-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81749/
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