FDA (Devices) recall action 97035
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 X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
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.
Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA requirements.
Spectral Instruments Inc is recalling the Ami HTX X-ray instrument because the safety and manufacturing date labels do not match FDA requirements.