Stephanix: Medical Device Recall in 2018 - (Recall #: Z-0557-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: November 2, 2018

Date Posted: December 12, 2018

Recall Number: Z-0557-2019

Event ID: 81582

Reason for Recall:

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

Status: Terminated

Product Quantity: 17 units

Code Information:

DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated