PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
⚠️ Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 26, 2026
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.
What's affected?
- Product
- Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
- Lot code
- System Model Numbers: (1)722068, (2)722226, (3)722236; UDI-DIs: (1)884838085367, (2)884838099272, (3)884838116801; Serial Numbers: All;
Additional details
System Model Numbers: (1)722068, (2)722226, (3)722236; UDI-DIs: (1)884838085367, (2)884838099272, (3)884838116801; Serial Numbers: All;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1503 units (326 US, 1177 OUS).
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