PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20

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.

Allura Xper FD20; Model Number: 722028;

On December 15, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). b. Circulate this letter to all users so that they are aware of the issue. Keep this letter with the documentation of the system until Philips inspects and, where needed, corrects your system. c. Establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. d. If you detect a burning odor, smoke, or fire originating from the R-cabinet in the technical room, immediately switch off the system s main power. Do not operate or use the system further. Follow your institution s emergency procedures. e. In case the affected system has been transferred to another organization, please send a copy of this letter to that organization and inform Philips about this transfer through your local Philips representative. f. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. g. Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative.

• FDA enforcement recordOfficial FDA database entry for Z-1075-2026
• FDA 510(k) clearance · K102005The device's official FDA premarket clearance record
• FDA 510(k) clearance · K130638The device's official FDA premarket clearance record
• FDA 510(k) clearance · K130842The device's official FDA premarket clearance record
• FDA 510(k) clearance · K133292The device's official FDA premarket clearance record
• FDA 510(k) clearance · K141979The device's official FDA premarket clearance record
• FDA 510(k) clearance · K161563The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.