Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0259-2024 — Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

U.S. FDA — Device Enforcement · United States · 2020-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0259-2024
Date of alert
2020-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Percussionaire Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00849436000068
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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