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Completed

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

FDA Recall Z-0259-2024 · Posted 2023-11-07

Recalling FirmPercussionaire Corporation
Recall StatusCompleted
Product CodeCBK
Date Initiated2020-09-14
Product Quantity212

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.

Firm Action

Waveform analyzers were serviced from September 2020 through September 2021.

Root Cause

Device Design

Distribution Pattern

US: CA, ND, MS, MD

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K905235VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESSPercussionaire Corp. · 1991-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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