FDA DevicesClass II
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Softwa...
Published: February 18, 2026Recall ID: Z-1344-2026Category: devicesCountry: US
Reason for Recall / Hazard
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Product Description & Identification
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Affected Products
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| State | N/A |
| Event id | 98326 |
| Address 1 | Veenpluis 4-6 |
| Address 2 | N/A |
| Code info | System Model Numbers: (1) 722063, (2) 722221, (3) 722229; UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726; Serial Numbers: All; |
| Postal code | N/A |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 291 units (27 US, 264 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260126 |
| Initial firm notification | N/A |
| Center classification date | 20260211 |
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.