Vitrea
Canon Medical Informatics, Inc. · Model 6.9.2 · UDI-DI 00853866003254
Description
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | PHILIPS MEDICAL SYSTEMS | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. |
| 2026-08-18 | Philips North America Llc | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
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