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Stephanix recalls STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Di
Recalled December 12, 2018 · FDA recall Z-0557-2019 · 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. · FDA Class II
Units
17 units
Sold at
US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
Description
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
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.
Manufacturer(s)
Stephanix
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →