Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1695-2025 — 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-ris

U.S. FDA — Device Enforcement · United Kingdom · 2025-03-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1695-2025
Date of alert: 2025-03-19
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Spectrum Medical Ltd.
Product category: device
Product type: Devices

Reported risk: Medical device software marketed without FDA clearance .

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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