FDA (Devices) recall action 75383
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 Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
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.
Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.
Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.