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U.S. Department of Health and Human Services

Class 2 Device Recall STEPHANIX D2RS Digital Dynamic Remote System

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 Class 2 Device Recall STEPHANIX D2RS Digital Dynamic Remote Systemsee related information
Date Initiated by FirmNovember 02, 2018
Create DateDecember 05, 2018
Recall Status1 Terminated 3 on July 25, 2021
Recall NumberZ-0557-2019
Recall Event ID 81582
510(K)NumberK102529 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSTEPHANIX 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.
Code Information DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062
FEI Number 3006972752
Recalling Firm/
Manufacturer		 Stephanix
Zone Industrielle Du Bayon
10 rue Jean Moulin
La Ricamarie France
For Additional Information Contact
561-997-3100
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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 in Commerce17 units
DistributionUS Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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