PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10

Recalling company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Allura Xper FD10; Model Number: 722010;

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 15, 2025

Reported

Jan 21, 2026

Distribution

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.

Status

Ongoing

Quantity

56 units

Lot / codes

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;

Company location

Best

Recall type

Voluntary: Firm initiated

Recall number

Z-1068-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1068-2026 in the FDA Enforcement Report. Also see FDA recall press releases.