FDA (Devices) recall action 72892
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.
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.
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.
The agency’s own wording, quoted from the enforcement report.
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.
GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.