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Use caution Medical device recall · FDA · Published November 3, 2023

Philips Azurion Systems with Monoplane Mounts May Fall Risk

Philips recalls Azurion 7 and 5 models with monoplane ceiling mounts that could fall if colliding with hospital equipment, risking injury or sterility issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0559-2024Medical devicePhilips ›
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Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands
✎ GovInfoNow plain-language explainer

Philips is recalling specific Azurion 7 and 5 models with monoplane ceiling mounts because a rotation cover might fall if it hits other hospital equipment, potentially causing injury or contamination. Read more at govinfonow.com/recall/56959-philips-azurion-systems-with-monoplane-mounts-may-fall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56959-philips-azurion-systems-with-monoplane-mounts-may-fall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0559-2024

Cite this page

“Philips Azurion Systems with Monoplane Mounts May Fall Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56959-philips-azurion-systems-with-monoplane-mounts-may-fall-risk. Based on FDA recall #Z-0559-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2024%22&limit=1).

The FDA announced on 2023-11-03 that Philips Medical Systems Nederland B.V. is recalling Philips Azurion systems with monoplane fixed ceiling mounts due to a hazard where the L-arm's rotation cover may fall upon collision, potentially causing injury or sterility issues. The recall affects 3,821 units distributed worldwide.

How to tell if you have it

  • Philips Azurion systems with monoplane fixed ceiling mounts
  • 722078 Azurion 7 M12
  • 722079 Azurion 7 M20
  • 722223 Azurion 7 M12
  • 722224 Azurion 7 M20
  • 722227 Azurion 5 M12
  • 722228 Azurion 5 M20
  • UPC 00884838085251
  • UPC 00884838085268
  • UPC 00884838099227
  • UPC 00884838099234
  • UPC 00884838099241
  • UPC 00884838099258

The hazard

The ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment, such as an operating light, were to occur. This fall could result in injury or potential sterility issues due to the cover becoming loose.

Context

GovInfoNow's records show PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 58 other recalls on record since 2021-05-26. Other recent recalls of similar products include Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (2026-02-23), Siemens ARTIS icono Ceiling Monitor Recall (2026-06-08), and Canon Alphenix X-ray Systems Recall (2026-08-04).

How to tell if you have this one

Check for the model numbers 722078, 722079, 722223, 722224, 722227, or 722228 on the Azurion 7 or 5 systems with monoplane fixed ceiling mounts.

  • Brand
    Philips
  • Product
    Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Recall numberProduct, codes & lotsQuantity
Z-0558-2024Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 12 (monoplane) 72246 Poly G - OMCP - VISUB - CCD (H5000); Model/Name/UDI-DI: 722001 Allura Xper FD10C; 722003 Allura Xper FD10; 722006 Allura Xper FD20 (01)00884838059115(21); 722010 Allura Xper FD10 (01)00884838059030(21); 722012 Allura Xper FD20 (01)00884838059054(21); 722015 Allura Xper FD20 OR Table; 722016 Integris H5000 C / Allura 9C ; 722018 Integris Allura 9; - 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table (01)00884838059085(21;) 722026 Allura Xper FD10 (01)00884838054189(21); 722028 Allura Xper FD20 (01)00884838054202(21); 722035 Allura Xper FD20 OR Table (01)00884838054240(21); 722043 Integris Allura 15 & 12 (monoplane).9991 units
Z-0559-2024Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20; Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).3821 units
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Look for model numbers 722078, 722079, 722223, 722224, 722227, or 722228 on the Azurion 7 or 5 systems with monoplane fixed ceiling mounts.

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: yesFLPuerto Rico: yesPR

FDA distribution: “Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China,…” 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 54 days after the firm started it.

1. Firm started the recall: Nov 3, 202312. FDA classified it Class II: Dec 15, 202323. Published in FDA’s Enforcement Report: Dec 27, 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-0559-2024 (November 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0559-2024 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