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Recall Observatory FDA recall evidence

Device product

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

Z-2688-2017

May 16, 2017

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    Software error