Sensis Vibe Systems with Software Version VD10B — Class II medical device recall Z-2688-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-07-12, distributed in IA, IN, MI. Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems g
| Recall number | Z-2688-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-05-16 |
| Classified | 2017-07-06 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-08-22 |
| Distributed | IA, IN, MI |
| Quantity | 13 units |
| Reason classes | software |
| Model numbers | 10765502, 10910620, 11007641, 6648161 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2688-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.