SOMATOM Confidence recall: Software Issue
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of…
Why was SOMATOM Confidence 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: 100172 100091 100112 100143 100158 100191 100107 100157 100137 100190 100092 100129 100136 100189 100156 100117 100097 100099 100174 100073 100016 100182 100146 100170 100175 100090 100160 100087 100025 100165 100147 100046 100140 100085
- Product
- SOMATOM Confidence, Model Number 10590100 - 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)