The issue was evaluated and replicated in the fmsu lab; the cause was traced to a software configuration.This issue is very rare and requires many tries with large studies to reproduce; it is considered to be a very rare occurrence in a clinical environment.Fujifilm has initiated a recall on 3/2/2021 to alert customers of several patient mismatch issues existing in all synapse pacs 5 versions.Fujifilm submitted c&r report 1000513161-03/11/2021-001-c to fda, which has been classified as class ii and assigned recall number z-1348-2021.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number (b)(4).
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On 04/16/2020, fujifilm medical systems u.S.A., inc.(fmsu) received a customer inquiry for assistance with synapse pacs.There was a issue noted is as follows: when the user attempts to open a study for patient a, incorrect patient data and images are displayed.There was no patient impact, serious injury or death associated with this event.The issue is considered highly detectable by a healthcare professional.
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