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Lower risk Medical device recall · FDA · Published August 1, 2025

Philips Allura Xper Series X-Ray System Recall: Missing Air Baffle Component

Philips recalls specific models of interventional fluoroscopic X-ray systems due to potential missing air baffle component. Affected units include Allura Xper FD10, FD20, and Biplane models with listed serial numbers. Contact Philips for details.

🇺🇸 FDA recall #Z-2504-2025Medical devicePhilips ›
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Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling certain models of interventional fluoroscopic X-ray systems (Allura Xper Series) because a component called an air baffle might be missing in some units. This could lead to improper function during medical procedures. Affected units have specific model numbers and serial numbers listed in the recall. Read more at govinfonow.com/recall/51706-philips-allura-xper-series-x-ray-system-recall-missing-air.

Source Summary by GovInfoNow · govinfonow.com/recall/51706-philips-allura-xper-series-x-ray-system-recall-missing-air · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2504-2025

Cite this page

“Philips Allura Xper Series X-Ray System Recall: Missing Air Baffle Component.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51706-philips-allura-xper-series-x-ray-system-recall-missing-air. Based on FDA recall #Z-2504-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2504-2025%22&limit=1).

Why it’s dangerous

The air baffle component is critical for proper function during interventional fluoroscopy procedures. If missing, it could cause improper system operation, potentially leading to inaccurate imaging or procedure complications.

Who’s affected

Medical facilities that own or use Philips Allura Xper Series X-ray systems with the listed model numbers and serial numbers are affected. Staff and patients using these systems during procedures may be at risk if the air baffle is missing.

How to tell if you have this one

Check if your Philips Allura Xper Series X-ray system has a model number listed in the recall (e.g., 722003, 722005, etc.) and the corresponding serial numbers provided in the document. The recall covers specific models and their serial numbers.

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

What to do — step by step

  1. Check Model and Serial Numbers

    Identify your Philips Allura Xper Series model number and serial number to confirm if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 28 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Aug 1, 202512. FDA classified it Class II: Sep 3, 202523. Published in FDA’s Enforcement Report: Sep 10, 202532025
  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.

✎ GovInfoNow

Questions people ask

Which Philips X-ray models are affected by this recall?

The recall affects Philips Allura Xper Series models with specific model numbers: FD10 (722003, 722010, 722026), FD20 (722006, 722012, 722028), FD20 Biplane (722008, 722013), and FD20/10 (722029). Each model has specific serial numbers listed in the recall.

What should I do if my system is affected?

Contact Philips directly to confirm if your system is affected and to get instructions for next steps. The recall does not include a specific remedy like repair or replacement.

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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-2504-2025 (August 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2504-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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