The Recall Desk

FDA (Devices) recall action 84655

GE Healthcare, LLC recalled 4 products on 2020-02-05

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-02-05
Critical
0
Units
—

Why these products were recalled

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

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

1–4 of 4

  • ModerateFDA (Devices)··2020-02-05

    GE Healthcare Recalls SIGNA Architect MRI Systems Due to Date Errors

    GE Healthcare is recalling SIGNA Architect MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-02-05

    GE Healthcare Recalls SIGNA Premier MRI Systems Due to Date Errors

    GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2020-02-05

    GE Healthcare Recalls SIGNA Pioneer MRI Systems Due to Date Errors

    GE Healthcare is recalling 62 SIGNA Pioneer MRI systems because an installation issue may cause incorrect dates on medical images.

    Product
    SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-02-05

    GE Healthcare Recalls MRI Systems Due to Potential Date Setting Error

    GE Healthcare is recalling 62 MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Distribution
    0 states