ddRCombi Plus FP — Class II medical device recall Z-0697-2019
Terminated recall by Swissray Medical AG, reported 2019-01-16, distributed in IL, MA. A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high cli
| Recall number | Z-0697-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Swissray Medical AG, Hochdorf, Switzerland |
| Recall initiated | 2018-11-14 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2021-09-01 |
| Distributed | IL, MA |
| Countries outside the US | CZ, DE, PE, PL |
| Quantity | 3 |
| Reason classes | device malfunction |
| Serial numbers | S403088, S403089, S403165 |
| Model numbers | 0070.0 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0697-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.