FDA-Device2018-12-12Class II
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
Stephanix
Hazard
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Sold states
US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
Affected count
17 units
Manufactured in
Zone Industrielle Du Bayon, 10 rue Jean Moulin, La Ricamarie, N/A, France
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2019Don't want to check this manually?
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