siemens medical solutions usa, incmedicalHigh PriorityActive

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. was recalled because during patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 20, 2026.

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Key facts

Date announced: April 15, 2026
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Siemens medical solutions usa, inc
Category: medical
Source agency: FDA
Announced: April 15, 2026
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

#	Model
1	ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1Stop using the affected product until you verify whether your item is impacted.
2Check the official recall notice and match your model, lot, or serial details.
3Follow the official instructions for repair, replacement, refund, or disposal.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: April 15, 2026
Last reviewed by RecallRadar: April 20, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325..

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the siemens medical solutions usa, inc recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1653-2026&limit=1

Keep browsing with these internal hubs: siemens medical solutions usa, inc recall hub and Medical recall hub.