Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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