STEPHANIX
STEPHANIX · Model D2RS · UDI-DI 03664049000017
JAA
Prescription
10
510(k) clearances
90,614
Adverse events (20 deaths)
223
Recalls
139
Facilities
Description
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections. Not for mammography.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-27 | Philips North America | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to mee |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea |
| 2024-07-29 | Agfa N.V. | Potential for the front lever chain of the DR 800 table to fail. |
| 2023-12-15 | Philips North America | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patie |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.