Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

FDA Device Recall #Z-1899-2019 — Class II — June 6, 2019

Recall Summary

Recall Number Z-1899-2019
Classification Class II — Moderate risk
Date Initiated June 6, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 131

Product Description

Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

Reason for Recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Distribution Pattern

Nationwide

Lot / Code Information

Serial Numbers: 109007 109057 109028 109027 109011 109021 109009 109010 109072 109075 109071 109041 109039 109032 109020 109036 109048 109088 109101 109040 109034 109031 109043 109067 109068 109093 109080 109179 109134 109133 109496 109076 109105 109104 109107 109084 109060 109164 109167 109135 109119 109090 109096 109091 109146 109102 109092 109189 109129 109143 109183 109606 109144 109171 109155 109217 109159 109172 109211 109169 109229 109166 109388 109350 109332 109210 109309 109203 109369 109300 109202 109401 109302 109346 109429 109214 109301 109311 109320 109330 109349 109373 109361 109231 109379 109331 109432 109434 109324 109417 109327 109344 109367 109435 109352 109380 109515 109461 109386 109365 109415 109366 109412 109383 109493 109518 109445 109437 109558 109526 109458 109424 109456 109451 109463 109467 109598 109484 109536 109538 109500 109501 109592 109527 109569 109627 109599 109591 109613 109610 109628

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.