medical Class II Updated 2025-05-07

Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VISION / LIVE VUE Product

Recalled Product

Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

Hazard / Issue

Medical device software marketed without FDA clearance .

Issued by

FDA

Distribution: California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, Mississippi
Lot/Code Info: All software revisions/No UDI
View official government recall

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