The Recall Desk

FDA (Devices) recall action 94508

Philips North America Llc recalled 30 products on 2024-05-29

The FDA (Devices) publishes a recall like this one as 30 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 30 pages.

Products
30
Announced
2024-05-29
Critical
0
Units
8,631

Why these products were recalled

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/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.

26–30 of 30

  • HighFDA (Devices)··2024-05-29

    Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard

    Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.

    Product
    SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-29

    Philips MRI System Recall: Loose Electrical Terminal May Cause Fire

    Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.

    Product
    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-29

    Philips Ingenia MRI Scanner Mains Distribution Unit Fire Risk Recall

    Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.

    Product
    Ingenia 1.5T S Model Number (REF): 781347
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-29

    Philips Achieva 3.0T PET imaging device poses potential fire hazard

    A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.

    Product
    Achieva 3.0T TX for PET Model Number (REF): 781479
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-29

    Philips Ingenia MR Systems Recalled for Fire Risk From Loose Connector

    Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.

    Product
    Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
    Category
    Distribution
    0 states