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Open, Classified

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

FDA Recall Z-1350-2026 · Posted 2026-02-11

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-01-26
Product Quantity326 units (10 US, 316 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.

Firm Action

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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01K181830Azurion R2.0Philips Medical Systems Nederland B.V. · 2018-08-02K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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