Exact FDA event identifier

Event 81582

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: November 02, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Stephanix

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0557-2019

Recall number: Z-0557-2019
Initiated: November 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Stephanix
Quantity: 17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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