Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1062-2026 — Product Name: Allura Xper FD10C; Model number: 722001;

U.S. FDA — Device Enforcement · Netherlands · 2025-12-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1062-2026
Date of alert
2025-12-15
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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