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Vitrea View

Canon Medical Informatics, Inc. · Model 7.0.1 · UDI-DI 00853866003261

LLZ
1
510(k) clearances
19,695
Adverse events (41 deaths)
554
Recalls
633
Facilities

Description

VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Recalls

DateFirmReason
2026-07-22Merge Healthcare, Inc.Software issue may cause measurements to be displayed inaccurately.
2026-07-22FUJIFILM Healthcare Americas CorporationSoftware issue may cause the ruler measurement to be inaccurate.
2026-06-30Merge Healthcare, Inc.Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30Merge Healthcare, Inc.Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-19Boston Scientific CorporationSoftware anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu
2026-05-08GE Medical Systems SCSGE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches
2026-03-19PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re
2026-03-05PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
2026-01-30GE Medical Systems, LLCThere is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w
2026-01-30GE Medical Systems, LLCThere is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w

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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.