Reported May 7, 2025 · Ongoing
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia…
Spectrum Medical Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectrum Medical Ltd. · Harrier 4, Meteor Business Park · Gloucester · N/A
Is this the product you have?
- Brand NameQuantum Informatics -
- VISION / LIVE VUE Product NameMonitor, Physiological, Patient (Without Arrhythmia Detection
- or Alarms) Product DescriptionVISION / 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
- Lot codes and dates
- All software revisions/No UDI
- Amount recalled
- 78 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Medical device software marketed without FDA clearance .
This product could cause temporary or reversible health problems — stop using it.
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