Z-2688-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- May 16, 2017
- Termination Date
- August 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 13 units
Product Description
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : IN, MI, IA
Code Information
Software Version VD10B