Z-0557-2019Class II

STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The...

Name: Z-0557-2019 STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The...
Creator: Stephanix
Published: 2018-11-02
License: https://open.fda.gov/license/

Stephanix / initiated 2018-11-02 / Terminated / root cause: software

FDA source

Stephanix began a recall of STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated... on 2018-11-02. FDA classified it as Class II and gives the reason as "The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0557-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-02
Posted: 2018-12-05
Terminated: 2021-07-25
Recalling firm: Stephanix
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA 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 in commerce: 17 units
Distribution: US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA
Product codes and lots: DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04

Product code OWB

K102529Class IID2rf Digital Dynamic Remote SystemStephanix Radiological Systems / cleared 2010-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)