CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report

D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/divisio recalled

Stephanix is recalling Stephanix D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/tr, distributed nationwide in the US. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062

Quantity recalled17 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0557-2019
FDA event ID: 81582
Recalling firm: Stephanix, La Ricamarie, N/A
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2018
FDA classified: 4 Dec 2018
Reported: 12 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

2 Nov 2018	Recall initiated by company
4 Dec 2018	Classified by FDA	+32 days
12 Dec 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA

Nationwide California Florida Georgia Indiana Missouri Pennsylvania Tennessee Wisconsin West Virginia

Questions about this recall

Is D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png recalled?

Yes. Stephanix recalled D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png on 2 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0557-2019.

Why was it 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.

Which lots are affected?

DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, DML062

Where was it sold?

US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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