Recall
FDAHealthDecember 15, 2025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD10; Model Number: 722010;

⚠️ Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 15, 2025

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.

What's affected?

Product
Allura Xper FD10; Model Number: 722010;
Lot code
Model Number: 722010; System Product Name: Allura Xper FD10; UDI-DI: 00884838059030; Serial Numbers: 764, 1396, 728, 980, 782, 125, 1096, 661, 225, 1055, 1185, 368, 743, 1006, 570, 901, 552, 973, 795, 888, 1140, 781, 1060, 354, 186, 516, 517, 64, 386, 387, 530, 996, 964, 1265, 525, 307, 1189, 98, 774, 935, 721, 254, 1008, 1213, 1273, 66, 156, 304, 1422, 388, 235, 236, 1066, 1090, 549, 689;

Additional details

Model Number: 722010; System Product Name: Allura Xper FD10; UDI-DI: 00884838059030; Serial Numbers: 764, 1396, 728, 980, 782, 125, 1096, 661, 225, 1055, 1185, 368, 743, 1006, 570, 901, 552, 973, 795, 888, 1140, 781, 1060, 354, 186, 516, 517, 64, 386, 387, 530, 996, 964, 1265, 525, 307, 1189, 98, 774, 935, 721, 254, 1008, 1213, 1273, 66, 156, 304, 1422, 388, 235, 236, 1066, 1090, 549, 689;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 56 units.

View original FDA notice →

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