Device Problems
Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Internally found issue.There was no patient involvement.Internally found issue.No incident date.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.
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Event Description
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Internally found issue.Distance measurements may not be calculated accurately by zero footprint versions 5.0 sp2 to sp7 when applied to images acquired with a magnification factor.
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Manufacturer Narrative
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The investigation determined the root cause was no documented zfpv requirements for specific dicom tags that developers can follow during design and implementation.Issue was resolved through normal development cycle in revision 6.0 of zfpv.
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Search Alerts/Recalls
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