FDA recall Z-0259-2024

Product

Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

Reason for recall

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.

Distribution

US: CA, ND, MS, MD

Key facts

Status

Completed

Initiation date

2020-09-14

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2024