Reported May 7, 2025 · Ongoing
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or…
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 - VIPER Product NameMonitor, Physiological, Patient (Without Arrhythmia Detection
- or Alarms) Product DescriptionVIPER 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). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events
- Lot codes and dates
- All software revisions/No UDI
- Amount recalled
- 156 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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