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Use caution Medical device recall · FDA · Published August 22, 2024

Philips Azurion 7 M20/5 M20/7 B20 Models: Cable Hose May Detach, Risk of Injury

Philips recalls Azurion 7 M20, 5 M20, and 7 B20 models due to potential cable hose detachment from broken plastic or bolts, which could cause parts to fall and injure users.

🇺🇸 FDA recall #Z-3165-2024Medical devicePhilips ›
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Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands
✎ GovInfoNow plain-language explainer

Philips is recalling several Azurion 7 and 5 models because a cable hose carrier could detach due to broken plastic or bolts. This might cause parts to fall and cause injury. Affected users should check their product details and take action if needed. Read more at govinfonow.com/recall/54177-philips-azurion-7-m20-5-m20-7-b20-models-cable.

Source Summary by GovInfoNow · govinfonow.com/recall/54177-philips-azurion-7-m20-5-m20-7-b20-models-cable · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3165-2024

Cite this page

“Philips Azurion 7 M20/5 M20/7 B20 Models: Cable Hose May Detach, Risk of Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54177-philips-azurion-7-m20-5-m20-7-b20-models-cable. Based on FDA recall #Z-3165-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3165-2024%22&limit=1).

The FDA announced on Aug. 22, 2024, that Philips Medical Systems Nederland B.V. is recalling Azurion imaging systems due to a potential detachment of the cable hose carrier. This defect may result in parts falling and causing injury.

How to tell if you have it

  • Brand: Philips
  • Product: Azurion 7 M20 (System Code Name: 722282)
  • Product: Azurion 5 M20 (System Code Name: 722281)
  • Product: Azurion 7 B20 (System Code Name: 722236)
  • Product: Azurion 7 B12 (System Code Name: 722235)
  • Product: Azurion 7 M20 (System Code Name: 722234)
  • Product: Azurion 7 M12 (System Code Name: 722233)
  • Product: Azurion 5 M20 (System Code Name: 722228)
  • Product: Azurion 5 M12 (System Code Name: 722227)
  • Product: Azurion 7 B20 (System Code Name: 722226)
  • Product: Azurion 7 B12 (System Code Name: 722225)
  • Product: Azurion 7 M20 (System Code Name: 722224)
  • Product: Azurion 7 M12 (System Code Name: 722223)
  • Product: Azurion 3 M15 (System Code Name: 722222)
  • Product: Azurion 3 M12 (System Code Name: 722221)
  • Product: Azurion 7 M20 (System Code Name: 722079)
  • Product: Azurion 7 M12 (System Code Name: 722078)
  • Product: Azurion 7 B20 (System Code Name: 722068)
  • Product: Azurion 7 B12 (System Code Name: 722067)
  • Product: Azurion 3 M15 (System Code Name: 722064)
  • Product: Azurion 3 M12 (System Code Name: 722063)
  • UPC: 00884838085251
  • UPC: 00884838085268
  • UPC: 00884838085275
  • UPC: 00884838085282
  • UPC: 00884838085350
  • UPC: 00884838085367
  • UPC: 00884838099203
  • UPC: 00884838099210
  • UPC: 00884838099227
  • UPC: 00884838099234
  • UPC: 00884838099241
  • UPC: 00884838099258
  • UPC: 00884838099265
  • UPC: 00884838099272
  • UPC: 00884838110564

The hazard

The recall involves a potential detachment of the cable hose carrier caused by broken plastic and/or bolts. This failure may result in parts falling or part of the cable hose dropping, which could lead to injury.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has issued 58 other recalls since May 26, 2021. Recent recalls include two on July 16, 2026, for Philips Azurion systems regarding potential image quality degradation and loss of geometry movements, and one on June 29, 2026, for a firmware issue leading to loss of geometry movements. Other recent recalls of similar products include the Philips CT 5300 Software Version 4.5-5.1 Recall (Oct. 29, 2025), the Draeger ErgoStar CM 60 Airway Connector Recall (Nov. 10, 2025), and the Genesis Screw-In Anchor Recall (Dec. 17, 2025).

How to tell if you have this one

Check for model numbers: Azurion 7 M20, Azurion 5 M20, or Azurion 7 B20. These models were sold with specific serial numbers listed in the recall notice.

  • Brand
    Philips
  • Product
    System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Nationwide, Canada and Worldwide: 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 Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe 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 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 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 Virgin Islands (U.S.) Yemen
Recall numberProduct, codes & lotsQuantity
Z-3165-2024System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079 Azurion 7 M20 722078 Azurion 7 M12 722068 Azurion 7 B20 722067 Azurion 7 B12 722064 Azurion 3 M15 722063 Azurion 3 M12; Model Product UDI-DI: 1. 722282 Azurion 7 M20 (01)00884838110571(21); 2. 722281 Azurion 5 M20 (01)00884838110564(21); 3. 722236 Azurion 7 B20 (01)00884838116801(21); 4. 722235 Azurion 7 B12 (01)00884838116788(21); 5. 722234 Azurion 7 M20 (01)00884838116771(21); 6. 722233 Azurion 7 M12 (01)00884838116764(21); 7. 722228 Azurion 5 M20 (01)00884838099234(21); 8. 722227 Azurion 5 M12 (01)00884838099227(21); 9. 722226 Azurion 7 B20 (01)00884838099272(21); 10. 722225 Azurion 7 B12 (01)00884838099265(21); 11. 722224 Azurion 7 M20 (01)00884838099258(21); 12. 722223 Azurion 7 M12 (01)00884838099241(21); 13. 722222 Azurion 3 M15 (01)00884838099210(21); 14. 722221 Azurion 3 M12 (01)00884838099203(21); 15. 722079 Azurion 7 M20 (01)00884838085268(21); 16. 722078 Azurion 7 M12 (01)00884838085251(21); 17. 722068 Azurion 7 B20 (01)00884838085367(21); 18.722067 Azurion 7 B12 (01)00884838085350(21); 19. 722064 Azurion 3 M15 (01)00884838085282(21); 20. 722063 Azurion 3 M12 (01)00884838085275(21) All serial numbers7091 units
Z-3166-2024System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025 Allura Xper FD20 Biplane OR Table 722023 Allura Xper FD20 OR Table 722020 Allura Xper FD20 Biplane OR Table 722015 Allura Xper FD20 OR Table 722013 Allura Xper FD20 Biplane 722012 Allura Xper FD20 722011 Allura Xper FD10/10 722010 Allura Xper FD10 722008 Allura Xper FD20 Biplane 722006 Allura Xper FD20 722005 Allura Xper FD10/10 722003 Allura Xper FD10 722002 Allura Xper FD10F 722001 Allura Xper FD10C; Model Product UDI-DI: 722059 Allura Xper FD20/15 OR Table (01)00884838059122(21) 722058 Allura Xper FD20/15 (01)00884838059115(21) 722039 Allura Xper FD20/20 OR Table - 722038 Allura Xper FD20/20 (01)00884838054226(21) 722035 Allura Xper FD20 OR Table (01)00884838054240(21) 722029 Allura Xper FD20/10 (01)00884838054219(21) 722028 Allura Xper FD20 (01)00884838054202(21) 722027 Allura Xper FD10/10 (01)00884838054196(21) 722026 Allura Xper FD10 (01)00884838054189(21) 722025 Allura Xper FD20 Biplane OR Table - 722023 Allura Xper FD20 OR Table - 722020 Allura Xper FD20 Biplane OR Table - 722015 Allura Xper FD20 OR Table - 722013 Allura Xper FD20 Biplane (01)00884838059061(21) 722012 Allura Xper FD20 (01)00884838059054(21) 722011 Allura Xper FD10/10 - 722010 Allura Xper FD10 (01)00884838059030(21) 722008 Allura Xper FD20 Biplane - 722006 Allura Xper FD20 (01)00884838055513(21) 722005 Allura Xper FD10/10 (01)00884838080805(10) 722003 Allura Xper FD10 (01)00884838059191(10) 722002 Allura Xper FD10F - 722001 Allura Xper FD10C - All Serial Numbers9318 units
Z-3167-2024System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C; Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers250 units
Z-3168-2024System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva; Model Product UDI-DI: N/A 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva All serial numbers109 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify your model by checking the product label for Azurion 7 M20, Azurion 5 M20, or Azurion 7 B20.

  2. Contact Philips Support

    Reach out to Philips customer support for assistance with the recall and next steps.

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, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia 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 34 days after the firm started it.

1. Firm started the recall: Aug 22, 202412. FDA classified it Class II: Sep 18, 202423. Published in FDA’s Enforcement Report: Sep 25, 202432024
  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-3165-2024 (August 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3165-2024 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