Spectrum Medical Ltd.: Device Recall
Recall #Z-1695-2025 · 03/19/2025
Recall Details
- Recall Number
- Z-1695-2025
- 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
- 156 systems
Reason for Recall
Medical device software marketed without FDA clearance .
Product 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.
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