Artis Pheno. Image-Intensified Flouroscopic X-Ray recall
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Why was Artis Pheno. Image-Intensified Flouroscopic X-Ray recalled?
Limited system movements after startup .
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?
Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097,
- Product
- Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)