Philips Medical Systems recalled 23 units of the Allura Xper FD20 Biplane on December 15, 2025. The recall affects systems with improperly installed drip trays, posing an electrical hazard. Health providers and patients must stop using the device immediately.
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 Biplane, Model Number 722013. The units were distributed worldwide, including the US and countries such as Argentina, Australia, and Brazil. The recall does not specify a price.
A limited number of affected systems lack proper installation of the drip tray beneath the cooling unit. This defect can allow coolant to contact electrical components, potentially causing short circuits and system shutdown.
There have been no reported injuries or deaths associated with this recall. The potential for short circuits remains a serious concern, classified as a high hazard.
Patients and healthcare providers should stop using the Allura Xper FD20 Biplane immediately. Contact Philips Medical Systems for further instructions and follow the recall guidelines provided.
For more information, call Philips Medical Systems at the number provided in recall letters or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1071-2026.
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