Company:Elekta, Inc.
Date of Enforcement Report:6/25/2014
Class lI:
PRODUCT
Synergy XVI Intended for radiation therapy treatment.
Recall Number Z-1724-2014
REASON
XVI can incorrectly calculate the target position of the treatment table..
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 4/23/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
380 US
DISTRIBUTION
Nationwide and Internationally
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