FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Azurion imaging systems recalled for software issues causing system restarts

OTHERNationwide distributionMedical devices

What this means

Philips Azurion X-ray imaging systems running software versions R2.1.10 or R2.2.10 may experience six different software problems. These include unexpected system restarts, continuous restart loops, storage space issues, and positioning errors that could affect image quality or system availability.

Check if your Azurion system model number is on the recall list (3 M12, 3 M15, 5 M12, 5 M20, 7 B12, 7 B20, or 7 M12)
Verify your system's software version (R2.1.10 or R2.2.10)
Contact Philips Medical Systems immediately for software updates or guidance
Do not ignore system restart warnings or positioning errors

The agency's original wording

Hazard

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Korea, South, 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 Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine/United Arab Emirate, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Vietnam, Yemen.

Affected count

10,466 units

Manufactured in

Veenpluis 4-6, Best, Netherlands

Products

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2026

More Philips recalls

FDA-Device2026-06-24
Philips Allura Xper imaging systems recalled for hand switch button malfunction risk
FDA-Device2026-06-24
Philips MultiDiagnost Eleva X-ray systems recalled for hand switch button malfunction risk

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.