Allura Xper FD10F recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIOngoing
Summary: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Allura Xper FD10F; Model Number: 722002;. 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.
What is being recalled
Allura Xper FD10F; Model Number: 722002;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
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;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1063-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 15, 2025 |
| Reported | January 21, 2026 |
| Company | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Company location | Best, Netherlands |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 units |
More recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · all medical device recalls · recalls from December 2025