Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1068-2026

Z-1068-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-1068-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on December 15, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 56 units.

Recall Details

Product Type: Devices
Report Date: January 21, 2026
Initiation Date: December 15, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56 units

Product Description

Allura Xper FD10; Model Number: 722010;

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 Pattern

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.

Code Information

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;

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