FDA (Devices) recall action 93264
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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 recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.
Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.
Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.
Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.
Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.
Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.