—#218252

Product

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172822, K181830, K200917
Affected lot / code info: System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)N/A; Serial Numbers: All;

Why it was recalled

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Root cause (FDA determination)

Device Design

Action the firm took

On January 26, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. " Read and follow the additional instructions in Appendix A regarding the use and configuration of the Reset Geometry function. " Keep Appendix A together with the documentation of the system. Ensure that the letter is in a place likely to be seen/viewed. " Confirm the Reset Geometry function that best suits your clinical workflow. If required, you may request Philips to change the settings. When using a third-party stand-alone device or a stationary accessory. You can request a configuration change free of charge within six (6) months from the date of this Urgent Medical Device Correction letter by contacting your local Philips representative. " In case the affected system has been transferred to another organization, please send a copy of this URGENT Medical Device Correction letter to that organization and inform Philips.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, 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, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.

Timeline

Recall initiated: 2026-01-26
Posted by FDA: 2026-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.