FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Azurion Systems R3.0 recalled for software issues affecting X-ray imaging

OTHERNationwide distribution

Contact Philips about your Azurion System software

Philips Medical Systems has recalled Azurion Systems R3.0 due to nine software issues that may cause X-ray loss, system restarts, display problems, or imaging misalignment during procedures. These issues could affect image quality and system reliability in clinical use.

Check if your Azurion System model (722229–722236) is running software version R3.0
Contact Philips Medical Systems immediately for a software update or further instructions
Do not use the system if you experience X-ray loss, continuous restarts, or imaging problems
Verify the UDI number on your device matches those listed in the recall notice

Hazard

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

Sold states

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.

Affected count

990 units

Manufactured in

Veenpluis 4-6, Best, Netherlands

Products

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2026

More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls

FDA-Device2026-06-03
Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
FDA-Device2026-06-03
Philips Allura medical imaging systems recalled for hard drive failure risk
FDA-Device2026-05-27
Philips Azurion X-ray systems recalled for cooling hose degradation risk
FDA-Device2026-05-27
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FDA-Device2026-05-27
Philips Azurion X-ray systems recalled for impaired table movement due to control wear

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