SOMATOM Definition Edge recall: Software Issue
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of…
Why was SOMATOM Definition Edge recalled?
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
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?
Serial Numbers: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823
- Product
- SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- N/A
- Distribution
- US Nationwide distribution.
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)