Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Summary
The FDA issued a Class II for Artis Pheno. Image-Intensified Flouroscopic X-Ray System. by Siemens Medical Solutions USA, Inc. Reason: Limited system movements after startup ..
Details
Source
Device Recall
External ID
Z-2529-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
Product Description
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Lot/Code Info: 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,
Quantity Affected: 20 units
Reason for Recall
Limited system movements after startup .
Distribution
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-12
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2529-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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