SOMATOM Edge Plus recall: Software Issue
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of…
Why was SOMATOM Edge Plus 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: 122022 122020 122008 122036 122029 122044 122037 122009 122038 122035 122041 122011 122034 122004
- Product
- SOMATOM Edge Plus, Model Number 10267000 - 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)