FDA Device recall Z-2688-2017
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2688-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-16 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | IA, IN, MI |
Product
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
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.
Identifiers
| code_info | Software Version VD10B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2688-2017%22
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