Class IIReported 2026-01-21

Allura Xper FD10F; Model Number: 722002;

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

Recall Number

Z-1063-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-15

Reported

2026-01-21

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.

Code Info

Model Number: 722002; System Product Name: Allura Xper FD10F; UDI-DI: N/A; Serial Numbers: 61, 56, 27, 81, 25, 85, 20, 21, 84, 50, 31, 40;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.