The Recall Desk

FDA (Devices) recall action 72892

GE Medical Systems, LLC recalled 2 products on 2018-10-31

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
2018-10-31
Critical
0
Units
—

Why these products were recalled

Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-10-31

    GE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk

    GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.

    Product
    GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2018-10-31

    GE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk

    GE Medical Systems is recalling 356 Discovery 3.0T MR750 MRI scanners because a specific coil can overheat in Mode 2, posing a risk of serious patient thermal injury.

    Product
    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
    Category
    Distribution
    26 states