FDA-Device2023-11-15Class II
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Percussionaire Corporation
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.
Sold states
US: CA, ND, MS, MD
Affected count
212
Manufactured in
130 Mcghee Rd Ste 109, Sandpoint, ID, United States
Products
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief