Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2630-2025

Z-2630-2025 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Recall Details

Product Type
Devices
Report Date
October 1, 2025
Initiation Date
September 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75 units (26 US, 49 OUS)

Product Description

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Reason for Recall

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Code Information

Product Code: 722038; UDI-DI: 00884838054226; Serial numbers: 39, 63, 42, 55, 67, 99, 60, 71, 115, 78, 106, 118, 130, 49, 119, 126, 173, 37, 38, 48, 62, 35, 137, 131, 70, 46, 102, 122, 121, 113, 152, 111, 138, 14, 127, 94, 93, 132, 92, 89, 88, 66, 30, 58, 29, 170, 28, 47, 104, 112, 50, 116, 79, 98, 31, 3, 123, 32, 5, 9, 27, 105, 69, 40, 75, 11, 73, 133, 110, 72, 117, 68, 64, 45, 109;

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-1344-2026 Class II — Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Softwa (January 26, 2026)
  • Z-1345-2026 Class II — Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7222 (January 26, 2026)
  • Z-1350-2026 Class II — Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Num (January 26, 2026)
  • Z-1351-2026 Class II — Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); (January 26, 2026)
  • Z-1349-2026 Class II — Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282( (January 26, 2026)
  • Z-1346-2026 Class II — Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Softwar (January 26, 2026)
  • Z-1348-2026 Class II — Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software (January 26, 2026)
  • Z-1347-2026 Class II — Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software (January 26, 2026)
  • Z-1068-2026 Class II — Allura Xper FD10; Model Number: 722010; (December 15, 2025)
  • Z-1072-2026 Class II — Allura Xper FD20 OR Table; Model Number: 722023; (December 15, 2025)