interventional fluoroscopic x-ray system recall: Software Issue
interventional fluoroscopic x-ray system
Why was interventional fluoroscopic x-ray system recalled?
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
4056869295923
- Product
- interventional fluoroscopic x-ray system
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Distribution
- Worldwide.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)