STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts — Class II medical device recall Z-0557-2019
Terminated recall by Stephanix, reported 2018-12-12, distributed nationwide. The firm has detected a potential risk using the command. After releasing the command, the movement of the tab
| Recall number | Z-0557-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stephanix, La Ricamarie, N/A, France |
| Recall initiated | 2018-11-02 |
| Classified | 2018-12-04 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2021-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 17 units |
Product
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Reason for recall
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
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-0557-2019. 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.