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[Recalled] 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-ti

recall fda device united-kingdom

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductBrand 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
Brand / manufacturerSpectrum Medical Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1695-2025
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date19 March 2025

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Medical device software marketed without FDA clearance .

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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