Philips Medical Systems recalled 21 units of the Allura Xper FD10/10 system on December 15, 2025. A defect in the drip tray could cause coolant to contact electrical components, posing a high risk of electrical short-circuits. Users should stop using the device immediately and follow recall instructions.
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 recalled product is the Allura Xper FD10/10, Model Number 722011. It was distributed worldwide, including the United States and several other countries. No retail price is mentioned.
The defect involves the drip tray beneath the cooling unit, which may not have been installed correctly. This can lead to coolant leaking onto electrical components, increasing the risk of short-circuits and system shutdown.
There have been no reported injuries or incidents directly linked to this defect as of now. The recall is precautionary.
Stop using the Allura Xper FD10/10 system immediately. Contact Philips Medical Systems for further instructions on how to proceed. Notifications will be sent out by letter.
For more details, contact Philips Medical Systems Nederland B.V. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1069-2026.
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