# FDA recall Z-1695-2025

> **Spectrum Medical Ltd.** · Class II · device recall initiated 2025-03-19.

## 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 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

## Key facts

- **Recall number:** Z-1695-2025
- **Recalling firm:** Spectrum Medical Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-19
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gloucester, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2025

## Citation

> AI Analytics. FDA recall Z-1695-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1695-2025. Source: US FDA. Licensed CC0.

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