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FDA (Device enforcement)Recalled 2025-12-15class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20; Model Number: 722028;

Hazard

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.

Details from the source

Reason for recall: 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. 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 Quantity: 2 units Lot/code info: Model Number: 722028; System Product Name: Allura Xper FD20; UDI-DI: 00884838054202; Serial Numbers: 893, 614;

UPC codes

00884838054202

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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