FDA-Device2023-06-07Class II
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224
Hazard
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Sold states
Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen
Affected count
USA: 1063 R.O.W. 2136
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1647-2023More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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