Health Canada — Medical Devices · Canada · 2016-05-16 · Type II
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Reported risk: Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. This could result in sensors that will either not provide readings for the SpCO and SpMet parameters or inaccurate readings. The specific behavior will depend on the firmware version of the technology board in the device. SpCO measurements, when displayed, could be incorrectly elevated throughout the measurement range. SpMet measurements above 6% could be affected by a negative bias of 1.5%, on average.
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