Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnosti...
FDA Device Recall #Z-0301-2022 — Class II — October 20, 2021
Recall Summary
| Recall Number | Z-0301-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 20, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 67 units |
Product Description
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
Reason for Recall
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014
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.