ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-2205-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
The recalled product
- Product
- ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 4056869046877
Distribution
Distribution scope not specified by the agency.
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