Device product
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Z-3211-2018
Product summary
- Event
- Event 80933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 259 units
- Official record key
device-enforcement:Z-3211-2018
Official wording
Reason: 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
Code information: All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
Distribution pattern: 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.
Derived failure modes
-
Unknown
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