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Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Recalled November 15, 2023 · FDA recall Z-0259-2024 · Percussionaire
Hazard
Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware. · FDA Class II
Units
212
Sold at
US: CA, ND, MS, MD
Description
Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.
Product
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Manufacturer(s)
Percussionaire Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →