FDA (Devices) recall action 98992
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.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
The agency’s own wording, quoted from the enforcement report.
ARTIS pheno interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.
ARTIS Icono interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.