Company: Elekta, Inc.
Date of Enforcement Report 8/31/2016
Class lI:
PRODUCT
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Recall Number Z-2691-2016
REASON
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 8/18/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13
DISTRIBUTION
US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
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