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Imorgon Medical, LLC

IMORGON MEDICAL LLC · Model Imorgon Report Accelerator 1.4 · UDI-DI 00863670000349

LLZ
1
510(k) clearances
19,647
Adverse events (41 deaths)
554
Recalls
633
Facilities

Description

imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

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.