H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling and applicable manufacture records.Based on a review of the information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of unit is not recognizing the sony printer was confirmed.The scanner could not detect the sony printer on software version 2.3.1.After updating the software to 3.0.1, the printer was detected.The root cause is due to a software version failure.H3 other text : evaluation findings are in section h11.
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