RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user in

FDA device recall Z-1081-2014 · posted 2014-03-06 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Action taken

Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 041 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of a mandatory upgrade to Integrity 1.2 upon its release which will prevent calibration from being inverted. For questions regarding this recall call 770-300-9725.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

489

Distribution

Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana,

Date initiated

2013-11-25

Date posted

2014-03-06

Date terminated

2015-08-13

Location

Atlanta, GA

Related 510(k) clearances