Percussionaire Corporation: Medical Device Recall in 2023 - (Recall #: Z-0259-2024)
See the recall detail below. You can also see other recalls from the same firm in 2023.
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Class II
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.
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
US: CA, ND, MS, MD
Voluntary: Firm initiated
