Axial3D Cloud Segmentation Service
AXIAL MEDICAL PRINTING LIMITED · Model 1 · UDI-DI 05065007075005
Description
Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgement.
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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