The Recall Desk

FDA (Devices) recall action 72301

GE Healthcare recalled 7 products on 2015-11-18

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2015-11-18
Critical
0
Units
1,509

Why these products were recalled

When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.

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.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls Signa HD 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 97 Signa HD 3.0T MRI systems because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room displa
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls Signa HDxt 3.0T MRI Scanners for SAR Limit Concerns

    GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls SIGNA PET/MR 3.0T Scanners for SAR Display Error

    GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquir
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 19 Signa 3.0T MRI systems because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The T
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls SIGNA Excite 3.0T MR Systems for SAR Display Error

    GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.

    Product
    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls Signa HDx 3.0T MRI Scanners for SAR Display Error

    GE Healthcare is recalling 350 Signa HDx 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-11-18

    GE Healthcare Recalls MRI Scanners Due to Potential SAR Limit Exceedance

    GE Healthcare is recalling 756 MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
    Category
    Distribution
    3 states