Stephanix recalls STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digi…

Recall date

November 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0557-2019

FDA classification

Class II

Brand / firm

Stephanix

Sold / distributed

US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA

Why it was recalled

The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.