Artis Pheno. Image-Intensified Flouroscopic X-Ray System recallZ-2529-2025 · Siemens Medical Solutions USA, Inc · initiated Aug 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Limited system movements after startup .
FDA root cause category: Software design
What the company is doing
Consignees were mailed an URGENT: MEDICAL DEVICE CORRECTION notification dated 8/12/25. The notification informs consignees that the recall issue will be corrected via release of an Update Instruction AX032/25/S by appointment, which can be arranged by contacting 1-800-888-7436. Consignees are to disseminate the recall notification to all users of affected devices within their organization and to where product may be further distributed. Consignees are to return the completed recall response form via email to [email protected] or by certified mail.
Recall details
- Recall number
- Z-2529-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2025
- Posted by the FDA
- Sep 5, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 20 units
- Product code
- OWB
- FDA submissions
- K241572
- Distribution
- US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Product description
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
Other devices under the same FDA submission
3 devices cleared under K241572 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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