Recall Z-0557-2019— Stephanix

Name: FDA recall Z-0557-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-02

Class II · Terminated

Class II FDA medical device recall by Stephanix, initiated 2018-11-02, terminated 2021-07-25. It names one FDA 510(k) clearance: K102529. 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.. Reason: The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping..

Recalling firm: Stephanix
Classification: Class II
Status: Terminated
Initiated: 2018-11-02
Terminated: 2021-07-25
Firm location: La Ricamarie, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K102529 — D2RF DIGITAL DYNAMIC REMOTE SYSTEMStephanix Radiological Systems·cleared 2010-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.