Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic im...

FDA Device Recall #Z-0108-2021 — Class II — August 3, 2020

Recall Summary

Recall Number Z-0108-2021
Classification Class II — Moderate risk
Date Initiated August 3, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 124 U.S

Product Description

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

Reason for Recall

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Distribution Pattern

US Natonwide distribution.

Lot / Code Information

Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226

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.

More from Siemens Medical Soluti... Recalls by Firm Recall Reasons Device Safety Stats