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Use caution Medical device recall · FDA · Published January 13, 2025

Philips Azurion 3 M12 System Recall: Finger Entrapment Risk During Repositioning

Philips recalls Azurion 3 M12 systems with specific serial numbers due to risk of finger entrapment between table rails during patient repositioning. Affected units may cause finger injury to operators and service personnel.

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

🇺🇸 FDA recall #Z-1087-2025Medical 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 Azur:ion 3 M12 systems with serial numbers 722063 and 722221. The recall is because during manual patient table repositioning, fingers can get trapped between the table's rails, potentially causing injury to operators and service staff. Read more at govinfonow.com/recall/53089-philips-azurion-3-m12-system-recall-finger-entrapment-risk-during.

Source Summary by GovInfoNow · govinfonow.com/recall/53089-philips-azurion-3-m12-system-recall-finger-entrapment-risk-during · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1087-2025

Cite this page

“Philips Azurion 3 M12 System Recall: Finger Entrapment Risk During Repositioning.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53089-philips-azurion-3-m12-system-recall-finger-entrapment-risk-during. Based on FDA recall #Z-1087-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1087-2025%22&limit=1).

The FDA announced on Jan. 13, 2025, that Philips Medical Systems Nederland B.V. is recalling Azurion 3 M12 systems due to a potential finger entrapment hazard during manual repositioning of the patient tabletop. The recall affects nine units in the United States and 101 units overseas.

How to tell if you have it

  • Brand: Philips
  • Product: Azurion 3 M12 System
  • System Code: (1) 722063 (2) 722221
  • UDI: (1) 722063 00884838085275(21) (2) 722221 00884838099203(21)
  • Affected parts: AD7 and AD7X patient tables (both tilt and non-tilt versions)

The hazard

According to the FDA, a finger can become entrapped between the longitudinal guiding rails and the tabletop during manual repositioning of the patient table. This may result in an injury to operators and service personnel.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has 58 other recalls on record since May 26, 2021. Other recent recalls of similar products include the Philips IQon Spectral CT Recall (Jan. 7, 2026), the IMRIS ORT200 Operating Room Table Recall (Aug. 6, 2026), and the IMRIS ORT300 Operating Room Table Recall (Aug. 6, 2026).

How to tell if you have this one

Check for the Azurion 3 M12 system with serial numbers 722063 or 722221. The system code is listed in the recall notice as (1) 722063 and (2) 722221.

  • Brand
    Philips
  • Category
    Medical device
FDA recall event · 19 products

All 19 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 distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, 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, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.
Recall numberProduct, codes & lotsQuantity
Z-1076-2025Allura CV20 System Code: 722031; UDI: N/A119 units OUS
Z-1077-2025Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026; UDI: (1) 722003 00884838059191(10); (2) 722010 00884838059030(21); (3)722026 00884838054189(21).474 units US; 1908 units OUS
Z-1078-2025AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027; UDI: (1) 722005 00884838059191(10) 00884838080805(10) (2) 722011 --- (3) 722027 00884838054196(21)146 units US; 629 units OUS
Z-1079-2025Allura Xper FD10C System Code: (1) 722001; UDI: N/A1 unit OUS
Z-1080-2025AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028; UDI: (1) 722006 00884838055513(21) 00884838059115(21) 00884838059191(10) (2) 722012 00884838059054(21) (3) 722028 00884838054202(21)1528 units US; 3482 units OUS
Z-1081-2025AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013; UDI: (1) 722006 00884838055513(21) 00884838059115(21) 00884838059191(10) (2) 722012 00884838059054(21) (3) 722028 00884838054202(21)66 units US; 79 units OUS
Z-1082-2025AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025; UDI: N/A1 unit OUS
Z-1083-2025AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035; UDI: N/A1 unit US; 1 unit OUS
Z-1084-2025AlluraXperFD20/10 System Code: (1) 722029; UDI: 00884838054219(21)22 units US; 65 units OUS
Z-1085-2025Allura Xper FD20/20 System Code: (1) 722038; UDI: 00884838054226(21)33 units US; 82 units OUS
Z-1086-2025AlluraXperFD20/15 System Code: (1) 722058; UDI: 00884838059115(21)69 units US; 235 units OUS
Z-1087-2025Azurion 3 M12 System Code: (1) 722063 (2) 722221; UDI: (1) 722063 00884838085275(21) (2) 722221 00884838099203(21)9 units US; 101 units OUS
Z-1088-2025Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280; UDI: (1) 722064 00884838085282(21); (2) 722222 00884838099210(21); (3) 722280 00884838103276(21)42 units US; 661 units OUS
Z-1089-2025Azurion 5 M12 System Code: (1) 722227 (2) 722231; UDI: (1) 722227 00884838099227(21); (2) 722231 00884838116740(21)6 units US; 246 units OUS
Z-1090-2025Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281; UDI: (1) 722228 00884838099234(21); (2) 722232 00884838116757(21); (3) 722281 00884838110564(21)68 units US; 438 units OUS
Z-1091-2025Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235; UDI: (1) 722067 00884838085350(21); (2) 722225 00884838099265(21); (3) 722235 00884838116788(21)90 units US; 458 units OUS
Z-1092-2025Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236; UDI: (1) 722068 00884838085367(21); (2) 722226 00884838099272(21); (3) 722236 00884838116801(21)251 units US; 938 units OUS
Z-1093-2025Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233; UDI: (1) 722078 00884838085251(21); (2) 722223 00884838099241(21); (3) 722233 00884838116764(21)324 units US; 1390 units OUS
Z-1094-2025Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233; UDI: (1) 722224 00884838099258(21); (2) 722079 00884838085268(21); (3) 722234 00884838116771(21); (4) 722282 00884838110571(21)1346 units US; 2582 units
Based on the official FDA remedy

What to do — step by step

  1. Check System Serial Number

    Look for the system code on the device: 722063 or 722221.

  2. Contact Philips for Guidance

    Reach out to Philips directly for specific instructions on how to safely handle the device or if a fix is needed.

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: “Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei…” 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 30 days after the firm started it.

1. Firm started the recall: Jan 13, 202512. FDA classified it Class II: Feb 4, 202523. Published in FDA’s Enforcement Report: Feb 12, 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.

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Keep exploring

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-1087-2025 (January 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1087-2025 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