The Recall Desk

FDA (Devices) recall action 76810

Philips Electronics North America Corporation recalled 3 products on 2017-04-26

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-04-26
Critical
0
Units
20,976

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.

1–3 of 3

  • SevereFDA (Devices)··2017-04-26

    Philips UNIQ X-ray Systems Recalled for Potential Fire Hazard

    Philips is recalling UNIQ X-ray systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-04-26

    Philips Recalls Allura Xper Systems Due to Chiller Leak Fire Risk

    Philips is recalling specific Allura Xper medical imaging systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-04-26

    Philips Allura Xper Systems Recalled for Chiller Leak Fire Risk

    Philips is recalling specific Allura Xper systems equipped with Laird chillers because a leak in the cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010…
    Category
    Distribution
    0 states