Monitron II Waveform Analyzer recall
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Why was Monitron II Waveform Analyzer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
- Recalling firm
- Percussionaire Corporation
- Quantity
- 212
- Distribution
- US: CA, ND, MS, MD
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)