FDA (Devices) recall action 79360
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 rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
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.
Deerfield Imaging is recalling 16 IMRIS T2X tables because the rotational locking mechanisms can disengage, potentially causing unintended table movement.
Deerfield Imaging is recalling 15 IMRIS ORT100 tables because the rotational locking mechanisms can disengage, potentially causing unintended movement.