medical Class II Updated 2018-09-26

Accuray Incorporated recalls Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev

Recalled Product

Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems


Hazard / Issue

the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
View official government recall

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