SOMATOM Drive recall: Software Issue
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients…
Why was SOMATOM Drive 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: 105081 105152 105128 105123 105105 105150 105096 105047 105115 105086 105165 105121 105103 105141 105118 105109 105116 105080
- Product
- SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients…
- 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)