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3DSCOPE

DIREX SYSTEMS CORP. · Model 3DSCOPE · UDI-DI 00863499000322

JAA

510(k) clearances

90,614

Adverse events (20 deaths)

223

Recalls

137

Facilities

Description

3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-corporeal shockwave lithotripsy. 3Dscope enables: • Visualization of various objects on fluoroscopy images (for example, kidney stones). • Generation and storage of patient records. • Comparing images obtained at different times. • Generation and management of patient data files and fluoroscopy images. The device is composed of the following units: • Workstation Console, which contains the application software for the system indicators and image display of the following:  System status  Fluoroscopy images • Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:  Generator control  Image initial processing  Data transfer to the Workstation console.

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 me
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/p
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/p
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/p
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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Data 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.