Medical DeviceMay 7, 2025
Quantum Informatics - VIPER Monitor, Physiological, Patient recall — FDA Z-1695-2025
Medical device software marketed without FDA clearance .
Class IIFDA: OngoingSpectrum Medical Ltd.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMay 7, 2025
Quantum Informatics - VISION / LIVE VUE Monitor, Physiological, Patient recall — FDA Z-1696-2025
Medical device software marketed without FDA clearance .
Class IIFDA: OngoingSpectrum Medical Ltd.
Understanding this recall history
This page summarizes recall records in which the official source identifies Spectrum Medical Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.