Company:Elekta, Inc.
Date of Enforcement Report:3/12/2014
Class lI:

PRODUCT

1. Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Recall Number Z-1084-2014

2. Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Recall Number Z-1085-2014

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
1. 300
2. 134

DISTRIBUTION
Nationwide and Internationally

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