Spectrum Medical Ltd.: Device Recall
Recall #Z-1696-2025 · 03/19/2025
Recall Details
- Recall Number
- Z-1696-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spectrum Medical Ltd.
- Status
- Ongoing
- Date Initiated
- 03/19/2025
- Location
- Gloucester, N/A, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 systems
Reason for Recall
Medical device software marketed without FDA clearance .
Product Description
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.
Distribution Pattern
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
Other Recalls by Spectrum Medical Ltd.
- Class II: Risk 03/19/2025