FDA-Device2018-09-26Class II
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Accuray Incorporated
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
Sold states
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.
Affected count
259 units
Manufactured in
1240 Deming Way, N/A, Madison, WI, United States
Products
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3211-2018Don't want to check this manually?
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