FDA Device recall Z-0259-2024

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

FDA Device
Class II
completed
Published 2023-11-15

On 2023-11-15 the FDA classified a Class II recall of Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators by Percussionaire, citing 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 we….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0259-2024
Classification	Class II
Status	completed
Initiated	2020-09-14
Published	2023-11-15
Last updated	2026-09-13 11:56 UTC
Company	Percussionaire
Distribution	CA, MD, MS, ND

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.

Identifiers

code_info	UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377… UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, WF21158, WF21391, WF21165, WF21166, WF21168, WF21169, WF21170, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186, WF21187, WF21188, WF21189, WF21190, WF21192, WF21193, WF21194, WF21195, WF21196, WF21197, WF21198, WF21199, WF21200, WF21201, WF21202, WF21203, WF21204, WF21205, WF21206, WF21207, WF21208, WF21209, WF21210, WF21211, WF21212, WF21213, WF21214, WF21215, WF21217, WF21218, WF21219, WF21220, WF21221, WF21222, WF21223, WF21224, WF21225, WF21226, WF21227, WF21228, WF21229, WF21230, WF21231, WF21232, WF21233, WF21234, WF21235, WF21236, WF21237, WF21238, WF21239, WF21240, WF21241, WF21242, WF21243, WF21244, WF21245, WF21246, WF21247, WF21248, WF21249, WF21250, WF21251, WF21252, WF21253, WF21254, WF21255, WF21256, WF21257, WF21258, WF21259, WF21260, WF21261, WF21262, WF21263, WF21264, WF2126

code_info

UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377…

UDI-DI: 00849436000068, Serial Numbers: WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, WF21158, WF21391, WF21165, WF21166, WF21168, WF21169, WF21170, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186, WF21187, WF21188, WF21189, WF21190, WF21192, WF21193, WF21194, WF21195, WF21196, WF21197, WF21198, WF21199, WF21200, WF21201, WF21202, WF21203, WF21204, WF21205, WF21206, WF21207, WF21208, WF21209, WF21210, WF21211, WF21212, WF21213, WF21214, WF21215, WF21217, WF21218, WF21219, WF21220, WF21221, WF21222, WF21223, WF21224, WF21225, WF21226, WF21227, WF21228, WF21229, WF21230, WF21231, WF21232, WF21233, WF21234, WF21235, WF21236, WF21237, WF21238, WF21239, WF21240, WF21241, WF21242, WF21243, WF21244, WF21245, WF21246, WF21247, WF21248, WF21249, WF21250, WF21251, WF21252, WF21253, WF21254, WF21255, WF21256, WF21257, WF21258, WF21259, WF21260, WF21261, WF21262, WF21263, WF21264, WF2126

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0259-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.