Company:Elekta, Inc.
Date of Enforcement Report:3/12/2014
Class lI:
PRODUCT
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall Number Z-1081-2014
REASON
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value..
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 11/25/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
489
DISTRIBUTION
Nationwide and Internationally
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