The Enforcement Report for the week of March 20, 2013 lists the continuing recall of the Elekta Synergy XVI, a radiation therapy digital imager.
The Class II Recall includes the XVI R3.5.1, R4.2.1, and R4.5.1, used as part of a radiation therapy treatment process. Elekta Inc, Atlanta, recalled the 164 products because the DICOM tags do not contain sufficient information for the XVI to identify the different volumes that have the same name.
Nationwide distribution includes Washington, DC, Puerto Rico, and the states of Alabama, California, Florida, Maryland, Nevada, and more.
Visit the FDA site for the complete list and more information on recall number Z-0931-2013.
