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OBView
Digisonics Inc · Model 4.8 · UDI-DI 00857050006014
10
510(k) clearances
19,647
Adverse events (41 deaths)
554
Recalls
633
Facilities
Description
System, Image Processing, Radiological - Doctors reading Station
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-22 | Merge Healthcare, Inc. | Software issue may cause measurements to be displayed inaccurately. |
| 2026-07-22 | FUJIFILM Healthcare Americas Corporation | Software issue may cause the ruler measurement to be inaccurate. |
| 2026-06-30 | Merge 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 |
| 2026-06-30 | Merge 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 |
| 2026-06-19 | Boston Scientific Corporation | Software 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 |
| 2026-05-08 | GE Medical Systems SCS | GE 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 |
| 2026-03-19 | PHILIPS 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 |
| 2026-03-05 | PHILIPS 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. |
| 2026-01-30 | GE Medical Systems, LLC | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w |
| 2026-01-30 | GE Medical Systems, LLC | There 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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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.