FDA (Devices) recall action 94305
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.
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
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 Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall during use.
GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.
GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.
GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.
GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.
GE Healthcare recalls Allia IGS and related interventional fluoroscopic x-ray systems due to potentially missing adhesive on bolts. The defect could allow the detector/elevator or x-ray tube in the gantry assembly to fall.
GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.