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Recall Observatory FDA recall evidence

Device product

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

Z-1348-2026

January 26, 2026

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 98326
Status
Ongoing
Classification
Class II
Quantity
1979 units (365 US, 1614 OUS)
Official record key
device-enforcement:Z-1348-2026

Official wording

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

Code information: System Model Numbers: (1)722078, (2)722223, (3)722233; UDI-DIs: (1)884838085251, (2)884838099241, (3)884838116764; Serial Numbers: All;

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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