Company: Elekta Inc.
Date of Enforcement Report 6/1/2016
Class lI:
PRODUCT
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Recall Number Z-1705-2016
REASON
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data..
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 5/12/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
20
DISTRIBUTION
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
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