medical Class II Updated 2018-12-12

Stephanix recalls STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.g

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062
View official government recall

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