Philips Medical Systems recalled 93 Allura Xper FD10 systems on December 15, 2025, due to a potential electrical hazard. The issue arises from an improperly installed drip tray that may cause coolant to contact electrical components. This defect 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 affects Allura Xper FD10 systems with model number 722003. These units were distributed worldwide, including the U.S. and countries such as Australia, Brazil, and the United Kingdom.
The drip tray beneath the cooling unit may not have been installed correctly. This can allow coolant to leak onto electrical components, posing a risk of short circuits.
No specific injuries or incidents have been reported related to this recall. The potential for system shutdown due to electrical issues remains a concern.
Stop using the Allura Xper FD10 immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.
For more information, call Philips at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1064-2026.
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