FDA (Devices) recall action 74215
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.
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
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.
GE Healthcare is recalling 97 MSK 1.5T Extreme MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.
GE Healthcare is recalling 101 Optima 1.5T MR430s MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.