Device 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.
Z-0557-2019
Product summary
- Firm
- Stephanix
- Event
- Event 81582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-0557-2019
Official wording
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.
Code information: DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062
Distribution pattern: US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
Derived failure modes
-
Unknown
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.