Medical device recalls Moderate risk

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Number: 722026;

Recall date
December 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1073-2026
FDA classification
Class II
Brand / firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold / distributed
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, Ke…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Allura Xper FD10; Model Number: 722026;

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