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

Recall Z-2258-2026 — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).

U.S. FDA — Device Enforcement · Netherlands · 2026-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2258-2026
Date of alert
2026-04-30
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838085275
Reported risk: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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