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Lower risk Medical device recall · FDA · Published April 28, 2026

Philips Azurion Systems: Potential Safety Issue with Table Movements

Philips recalls Azurion systems not configured with auxiliary pan handle due to mechanical wear in Float Tabletop control affecting table movements. Affected models include Azurion 3 M12, M15, 5 M12, 5 M20, 7 B12, B20, and 7 M12/M20 series with specific model numbers.

🇺🇸 FDA recall #Z-2225-2026Medical devicePhilips ›
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Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 6 · Best, Netherlands
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling certain Azurion medical imaging systems that lack an optional auxiliary pan handle. This can cause mechanical wear in the Float Tabletop control, potentially impacting longitudinal and transverse table movements during use. The issue does not involve immediate safety risks but requires attention to prevent potential operational problems. Read more at govinfonow.com/recall/49330-philips-azurion-systems-potential-safety-issue-with-table-movements.

Source Summary by GovInfoNow · govinfonow.com/recall/49330-philips-azurion-systems-potential-safety-issue-with-table-movements · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2225-2026

Cite this page

“Philips Azurion Systems: Potential Safety Issue with Table Movements.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49330-philips-azurion-systems-potential-safety-issue-with-table-movements. Based on FDA recall #Z-2225-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2225-2026%22&limit=1).

Why it’s dangerous

The Float Tabletop control on the control module can experience mechanical wear over time, which may impact the system's ability to move the table smoothly in both longitudinal and transverse directions. This could lead to inaccurate positioning during medical imaging procedures.

Who’s affected

Medical facilities and healthcare professionals using Philips Azurion systems without the auxiliary pan handle. The risk is low as the issue affects table movement precision rather than causing injury.

How to tell if you have this one

Check if your Philips Azurion system has a model number matching the listed series (Azurion 3 M12, M15, 5 M12, 5 M20, 7 B12, B20, or 7 M12/M20) with the specific model numbers provided in the recall notice.

  • Brand
    Philips
  • Product
    Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Identify your system model

    Check the model number on your Philips Azurion system to see if it matches the affected models listed in the recall.

  2. Contact Philips

    Reach out to Philips customer support to confirm if your system is affected and to get instructions for resolution.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Apr 28, 202612. FDA classified it Class II: May 21, 202623. Published in FDA’s Enforcement Report: May 27, 202632026
  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-2225-2026 (April 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2225-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 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.
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