Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
- Recall Initiated
- January 26, 2026
- Posted
- February 11, 2026
- Recall Number
- Z-1349-2026
- Quantity
- 5136 units (1743 US, 3393 OUS)
Reason for Recall
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Distribution
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.
Lot / Code Info
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); UDI-DIs: (1)884838085268, (2)884838099258, (3)884838116771, (4)N/A; Serial Numbers: All;
Root Cause
Device Design
Action Taken
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.