PlainRecalls
FDA Devices Moderate Class II Terminated

Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,

Reported: July 12, 2017 Initiated: May 16, 2017 #Z-2688-2017

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.

Details

Units Affected
US: 13 units
Distribution
US Distribution to the states of : IN, MI, IA
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,. Recalled by Siemens Medical Solutions USA, Inc. Units affected: US: 13 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2688-2017.

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