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.

The firm initiated the recall by email on 11/02/2018 to the sole US distributor. This email included a letter to be provided to the end user. The letter directed the user as follows: "As a precautionary measure and before your usual maintenance team intervention, the user should look at the equipment during all of its movement (as stated in the user manual). Immediately release the command if an abnormal movement is detected. If necessary, use the closest emergency switch to stop the system." f you need more information or technical assistance, you can phone your usual contact.