The Recall Desk

FDA (Devices) recall action 89375

Philips North America Llc recalled 2 products on 2022-03-16

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-03-16
Critical
0
Units
1

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2022-03-16

    Philips Allura Xper X-ray systems cooling system leak poses fire risk

    Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-03-16

    Philips X-ray System Cooling Leak Poses Fire Risk

    Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.

    Product
    Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
    Category
    Distribution
    0 states