FDA (Devices) recall action 67184
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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 is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.
Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.
Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.