FDA (Devices) recall action 98099
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.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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.
Mobius Imaging is recalling 101 detachable 10in pendant replacement components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.