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

Recall Z-0724-2022 — Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72

U.S. FDA — Device Enforcement · United States · 2021-11-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0724-2022
Date of alert
2021-11-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838054189
Reported risk: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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