Recall Z-1695-2025— Spectrum Medical Ltd.
Class II · Ongoing
Class II FDA medical device recall by Spectrum Medical Ltd., initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Medical device software marketed without FDA clearance ..
- Recalling firm
- Spectrum Medical Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-19
- Firm location
- Gloucester, N/A, United Kingdom
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.
Reason for recall
Medical device software marketed without FDA clearance .
Data sourced from openFDA. This site is unofficial and independent of the FDA.