Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
FDA Recall Z-2688-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2017-05-16
Date Terminated2018-08-22
Product QuantityUS: 13 units
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.
Firm Action
Siemens sent an Customer Safety Advisory Notice dated May 16, 2017, was mailed to all users on May 16, 2017. The letter informs customers of the software issue and potential impact. Siemens Medical Solutions will contact users to make arrangements to update the system with updated software to correct the issue. For further questions, please call (610) 448-6461.
Root Cause
Software design
Distribution Pattern
US Distribution to the states of : IN, MI, IA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.