Based on the investigation and additional information received, siemens medical affairs identified this issue as low health risk (lhr) on 10/28/2015.As per procedure, siemens did retrospective review of all associated complaints with this issue and identified those with potential safety issues for which medical device reports need to be filed.Customer has been provided with new test paks.Customer indicated that new test paks were scanning without errors.System is operational.Siemens is revising the affected acute care testpak, calpak, and dilpak labeling to resolve this issue.Siemens is planning to issue an urgent field safety notice to notify affected siemens customers about this issue.
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