Recall Z-0259-2024— Percussionaire Corporation

Name: FDA recall Z-0259-2024
Creator: U.S. Food and Drug Administration
Published: 2020-09-14

Class II · Completed

Class II FDA medical device recall by Percussionaire Corporation, initiated 2020-09-14. It names one FDA 510(k) clearance: K905235. Product: Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.. Reason: 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..

Recalling firm: Percussionaire Corporation
Classification: Class II
Status: Completed
Initiated: 2020-09-14
Firm location: Sandpoint, ID, United States

510(k) clearances named in this recall

1 on FDA's record

K905235 — VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESSPercussionaire Corp.·cleared 1991-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.