Siemens Artis Q/Zen Biplane Recall: Ceiling Mount Screw Quality Issue
Siemens recalls Artis Q and Q.Zen biplane angiography systems due to potential ceiling mount screw quality issues that could affect safety standards.
Use caution until it’s fixed
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Contact the company
What happened, in plain English
Siemens is recalling Artis Q and Q.Zen biplane angiography systems because a ceiling mount connection might not be properly fastened with screws. This could lead to safety risks if the system isn't securely mounted. Read more at govinfonow.com/recall/73120-siemens-artis-q-zen-biplane-recall-ceiling-mount-screw-quality.
Source Summary by GovInfoNow · govinfonow.com/recall/73120-siemens-artis-q-zen-biplane-recall-ceiling-mount-screw-quality · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0508-2018
Cite this page
“Siemens Artis Q/Zen Biplane Recall: Ceiling Mount Screw Quality Issue.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73120-siemens-artis-q-zen-biplane-recall-ceiling-mount-screw-quality. Based on FDA recall #Z-0508-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0508-2018%22&limit=1).
Why it’s dangerous
The ceiling mount connection uses 12 screws that may not be attached correctly. If the screws aren't properly fastened, the system could become unstable or detach during use, potentially causing injury.
Who’s affected
Medical facilities using Artis Q or Q.Zen biplane systems are most at risk. Patients undergoing imaging procedures with these systems could be affected if the equipment isn't properly secured.
How to tell if you have this one
Check for Artis Q or Q.Zen biplane systems with serial numbers 10094141, 10848282, or 10848355. These systems were sold in specific regions and timeframes.
- Brand
Siemens- Category
Medical device
What to do — step by step
Check Mounting
Inspect the ceiling mount connection for properly fastened screws to ensure safety.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0508-2018 (August 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0508-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.