Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848...

FDA Device Recall #Z-0298-2021 — Class II — September 21, 2020

Recall Summary

Recall Number Z-0298-2021
Classification Class II — Moderate risk
Date Initiated September 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 22 units

Product Description

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Reason for Recall

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

Distribution Pattern

US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.

Lot / Code Information

Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383

Other Recalls from Siemens Medical Solutions USA, Inc

Recall # Classification Product Date
Z-1175-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1174-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1241-2026 Class II NAEOTOM Alpha.Prime Software applications: s... Dec 19, 2025
Z-1240-2026 Class II NAEOTOM Alpha Software applications: syngo.C... Dec 19, 2025
Z-1239-2026 Class II SOMATOM X.ceed Software applications: syngo.... Dec 19, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.