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Varex Digital Imaging Software, Nexus DR
VAREX IMAGING CORPORATION · Model v4.9 · UDI-DI 00854344007658
10
510(k) clearances
90,607
Adverse events (20 deaths)
223
Recalls
137
Facilities
Description
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
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.