FDA-Device2026-02-18Class IIPROCESSING DEFECT
Philips Azurion 3 M12 imaging system recalled for unexpected table movement
What this means
The table on certain Philips Azurion 3 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could create a safety risk in clinical settings. Philips has identified this issue and is working on a solution.
- If you operate or maintain an Azurion 3 M12 system, contact Philips Medical Systems immediately for guidance
- Do not use the Reset Geometry button until you receive updated instructions from Philips
- Check your system's model number (722063, 722221, or 722229) and software version (R1.X, R2.X, or R3.X) to confirm if your device is affected
The agency's original wording
Hazard
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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-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.
Affected count
291 units (27 US, 264 OUS)
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2026More Philips recalls
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