Recall Z-0557-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Stephanix
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 intervent
| Date | Nov 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 17 units |
| Distribution | US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102529 | D2RF DIGITAL DYNAMIC REMOTE SYSTEM Stephanix Radiological Systems, Oct 7, 2010 |