Health Canada — Medical Devices · Canada · 2015-08-11 · Type III
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Reported risk: Manufacturer became aware of the following: the "calibration expiry date is 9999-12-30 (never expires) could result in incorrect handling of incoming control. Frequent pop-up: "the period selected has an SD value of 0". Several periods may open in parallel for the same control. Error codes such as "pump warning 10" and "pump warning 14" appear during initialization of the instrument.
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