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

Recall date

August 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3211-2018

FDA classification

Class II

Brand / firm

Accuray Incorporated

Sold / distributed

Worldwide Distribution: United States (nationwide), and countries of: United Kingdom, Germany, France, Finland, Netherlands, Portugal, Hong Kong, Poland, Australia, United Arab Emirates, Thailand, and Japan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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