Recall Z-2688-2017 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
| Date | May 16, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | US: 13 units |
| Distribution | US Distribution to the states of : IN, MI, IA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020440 | NEWCOR Siemens Medical Systems, Inc., Dec 3, 2002 |