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ExamVue
JPI HEALTHCARE. CO., LTD. · Model ExamVue Duo · UDI-DI 08809413810679
1
510(k) clearances
1,231
Adverse events (5 deaths)
168
Recalls
82
Facilities
Description
ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-09 | FUJIFILM Healthcare Americas Corporation | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be suppl |
| 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 |
| 2025-09-15 | FUJIFILM Healthcare Americas Corporation | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
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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.