FDA Device recall Z-0557-2019
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote S…
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote S… by Stephanix, citing the firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0557-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-02 |
| Published | 2018-12-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stephanix |
| Distribution | US |
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
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Identifiers
| code_info | DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2019%22
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