Philips Medical Systems Nederland B.V. recalled two Allura Xper FD20 imaging systems on December 15, 2025. The recall follows concerns that the drip tray beneath the cooling unit may not have been properly installed. Failure to address this issue could lead to electrical short-circuits and system shutdowns.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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The recall involves the Allura Xper FD20 imaging systems, model number 722028. These systems were distributed worldwide, including in the U.S., Argentina, Australia, and many other countries. The affected UDI-DI is 00884838054202, with serial numbers 893 and 614.
Philips identified that a limited number of systems might have an uninstalled or inadequately documented drip tray. If the drip tray is missing, coolant liquid could contact electrical components, posing a risk of electrical short-circuits.
The current recall does not cite any reported injuries or incidents. However, the potential for electrical failure poses significant operational risks.
Patients and healthcare providers must stop using the Allura Xper FD20 systems immediately. Follow the manufacturer's recall instructions and contact Philips Medical Systems Nederland B.V. for guidance.
For more information, reach Philips at their official website or refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1075-2026.
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