FDA (Devices) recall action 78663
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.
Potential for positional errors following automatic table movement (ATM).
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.
Elekta Limited is recalling Agility with Integrity R3.2 software due to a potential for positional errors following automatic table movement.
Elekta Limited is recalling 539 Integrity R1.2 units due to a potential for positional errors following automatic table movement.