Recall Z-1696-2025— Spectrum Medical Ltd.
Class II · Ongoing
Class II FDA medical device recall by Spectrum Medical Ltd., initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Medical device software marketed without FDA clearance ..
- Recalling firm
- Spectrum Medical Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-19
- Firm location
- Gloucester, N/A, United Kingdom
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.
Reason for recall
Medical device software marketed without FDA clearance .
Data sourced from openFDA. This site is unofficial and independent of the FDA.