FDA Device recall Z-0697-2019
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, multifun…
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of 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, multifun… by Swissray Medical Ag, citing 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, whic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-14 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Swissray Medical Ag |
| Distribution | IL, MA |
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
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.
Identifiers
| code_info | Serial Numbers: S403088, S403089, S403165 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2019%22
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