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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