Health Canada — Medical Devices · Canada · 2015-09-24 · Type III
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Reported risk: In analyzers with older batteries (Run P0008 and below), the battery may overheat causing black smoke, burnt smell and loud noise. Temperature monitoring is in place to ensure shut down of the analyser upon overheating. However, heating of the cells may happen very fast, so that the temperature monitoring and shut down of the charging might not been able to stop the therminal runaway.
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