Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All software revisions/No UDI
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Spectrum Medical Ltd.
- Reason for Recall:
- Medical device software marketed without FDA clearance .
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER 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.
Product Codes/Lot Numbers:
All software revisions/No UDI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1695-2025
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