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.
Enforcement
- Recall Number
- Z-0557-2019
- Event ID
- 81582
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stephanix
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 12, 2018
- Initiation Date
- November 2, 2018
- Classification Date
- December 4, 2018
- Termination Date
- July 25, 2021
- Address
- Zone Industrielle Du Bayon, 10 rue Jean Moulin, La Ricamarie, N/A, N/A, France
Description
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.
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062
US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
17 units