Device product
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Z-2688-2017
Product summary
- Event
- Event 77324
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 13 units
- Official record key
device-enforcement:Z-2688-2017
Official wording
Reason: 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.
Code information: Software Version VD10B
Distribution pattern: US Distribution to the states of : IN, MI, IA
Derived failure modes
-
Device software or design
Software error