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FDAAugust 31, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

accuray

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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