nCommand Lite System
IONIC HEALTH TECHNOLOGIES S/A · Model Software version · UDI-DI 07898974112002
Description
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing system CT scanner. Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. This allows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to local regulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided. Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.
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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