FDA (Devices) recall action 71508
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
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 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
GE Healthcare is recalling seven Optima CL 323i angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
GE Healthcare is recalling eight Innova IGS 630 angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.
GE Healthcare is recalling three Innova IGS 620 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
GE Healthcare is recalling three Discovery and Innova IGS 740 angiographic X-ray systems because they may lose C-arm gantry motion capability.
GE Healthcare is recalling six Innova 3100IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
GE Healthcare is recalling two Innova 3131IQ angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
GE Healthcare is recalling four Discovery IGS 730 angiographic X-ray systems worldwide due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.
GE Healthcare is recalling three Optima IGS 320 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.