Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Recalled by Stephanix Due to The firm has detected a potential risk using...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stephanix directly.
Affected Products
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.
Quantity: 17 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stephanix
Stephanix has 1 total recall tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report