FDA (Devices) recall action 80177
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
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 Medical Systems is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors that may cause loss of imaging mode.
GE Medical Systems is recalling 102 Discovery IGS 740 systems because X-ray abort errors may cause loss of imaging mode during fluoroscopic use.
GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.