ORCANOS released a new RISK management system (ISO 14971), based on recent RECALL CLASS 1 by the FDA, to include RISK analysis covering recent incident of potential flammability of battery used by the device. The new release includes also mitigation procedure for that case as well.
Hazard: Battery overheated on the device unit while charging in standby mode during a routine procedure
Failure Cause: Manufacturing Failure
Failure Effect/ Harm: System flammability causing fire or wrong function
Risk Control (RISK-2277): Register for the free trial on: https://lnkd.in/ghv8YX6
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