Siemens Medical Solutions USA, Inc recalls Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable d…

Recall date

May 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2688-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Distribution to the states of : IN, MI, IA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,