A field service engineer was dispatched to the customer site and identified the reported smoke was ¿exhaust fumes¿ due to a loose oil mist filter.The vacuum pump oil, catalytic converter and oil mist filter were replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the smoke/haze issue for the sterrad 100nx unit was reviewed for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for return and further analysis.The assignable cause of the smoke/haze issue is likely due to the oil mist filter, catalytic converter and vacuum pump oil.The field service engineer replaced these parts and confirmed the sterrad® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
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