Z-3211-2018 Class II Terminated
FDA device recall Z-3211-2018 was initiated by Accuray Incorporated on August 31, 2018 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated December 16, 2020). Affected quantity: 259 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- August 31, 2018
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 259 units
Product Description
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Reason for Recall
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
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.
Code Information
All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018