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.
- Company
- Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom
- Recall Initiated
- March 19, 2025
- Posted
- April 29, 2025
- Recall Number
- Z-1695-2025
- Quantity
- 156 systems
Reason for Recall
Medical device software marketed without FDA clearance .
Distribution
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
Lot / Code Info
All software revisions/No UDI
Root Cause
No Marketing Application
Action Taken
On March 19, 2025 Spectrum Medical Inc. issued a "Urgent Medical Device Notification" to affected consignees via E-Mail. Spectrum Medical asked consignees to take the following actions: 1. Identify all users of these apps in your facility. 2. Conduct a risk assessment to determine if continued use of these apps is appropriate for your facility 3. Share this notice with all affected parties. 4. Complete the attached response form and return it to us at regulatory@spectrummedical.com.