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Recall Observatory FDA recall evidence

Device product

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

Z-0259-2024

September 14, 2020

Class II

Product summary

Firm
Percussionaire Corporation
Event
Event 93192
Status
Completed
Classification
Class II
Quantity
212
Official record key
device-enforcement:Z-0259-2024

Official wording

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.

Code information: 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, WF21265, WF21266, WF21267, WF21268, WF21269, WF21270, WF21271, WF21272, WF21273, WF21274, WF21275, WF21276, WF21277, WF21278, WF21279, WF21280, WF21281, WF21282, WF21283, WF21284, WF21285, WF21286, WF21287, WF21288, WF21289, WF21290, WF21291, WF21292, WF21293, WF21294, WF21295, WF21296, WF21297, WF21298, WF21299, WF21300, WF21301, WF21302, WF21303, WF21304, WF21305, WF21306, WF21307, WF21308, WF21309, WF21310, WF21311, WF21312, WF21313, WF21314, WF21315, WF21316, WF21317, WF21318, WF21319, WF21320, WF21321, WF21322, WF21323, WF21324, WF21325, WF21326, WF21327, WF21328, WF21329, WF21330, WF21331, WF21332, WF21333, WF21334, WF21335, WF21336, WF21337, WF21338, WF21339, WF21340, WF21341, WF21342, WF21343, WF21344, WF21345, WF21346, WF21347, WF21348, WF21349, WF21350, WF21351, WF21352, WF21353, WF21354, WF21355, WF21356, WF21357, WF21358, WF21359, WF21360, WF21361, WF21362, WF21363, WF21364, WF21365, WF21366, WF21367, WF21368, WF21369, WF21370

Distribution pattern: US: CA, ND, MS, MD

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.