Sensis Vibe Systems with Software Version VD10B recall: Software Issue
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Why was Sensis Vibe Systems with Software Version VD10B 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version VD10B
- Product
- Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- US: 13 units
- Distribution
- US Distribution to the states of : IN, MI, IA
- Recall date
- July 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)