FDA-Device2017-07-12Class II
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Siemens Medical Solutions USA, Inc
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.
Sold states
US Distribution to the states of : IN, MI, IA
Affected count
US: 13 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2688-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief