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Lower risk Medical device recall · FDA · Published March 21, 2023

Siemens ARTIS One Angiography System Recall: Monitor Display Issue

Siemens recalls ARTIS One angiography systems with hybrid cables that may have no image display. Affected units have specific serial numbers; contact for remedy.

🇺🇸 FDA recall #Z-1469-2023Medical deviceSiemens ›
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Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens is recalling ARTIS One angiography systems with a hybrid cable that may not display images. This could prevent proper medical imaging during procedures, which is critical for patient safety. Read more at govinfonow.com/recall/58725-siemens-artis-one-angiography-system-recall-monitor-display-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/58725-siemens-artis-one-angiography-system-recall-monitor-display-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1469-2023

Cite this page

“Siemens ARTIS One Angiography System Recall: Monitor Display Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58725-siemens-artis-one-angiography-system-recall-monitor-display-issue. Based on FDA recall #Z-1469-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1469-2023%22&limit=1).

Why it’s dangerous

The monitor connected via the hybrid cable may fail to show images, leading to inability to visualize during critical medical procedures. This could result in missed diagnoses or incorrect treatments.

Who’s affected

Healthcare facilities using the affected Siemens ARTIS One systems with hybrid cables. Medical staff and patients using these systems during procedures are at risk of incomplete imaging.

How to tell if you have this one

Check the serial numbers listed in the recall notice: US serial numbers start with 825xx or 826xx, and OUS serial numbers start with 826xx. The system is an angiography device for diagnostic imaging and interventional procedures.

  • Brand
    Siemens
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Verify if your system has a US or OUS serial number matching the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Puerto Rico, South Dakota.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Mar 21, 202312. FDA classified it Class II: Apr 27, 202323. Published in FDA’s Enforcement Report: May 3, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1469-2023 (March 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1469-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA