Recall Z-3211-2018— Accuray Incorporated
Class II · Terminated
Class II FDA medical device recall by Accuray Incorporated, initiated 2018-08-31, terminated 2020-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems. 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.
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-31
- Terminated
- 2020-12-16
- Firm location
- Madison, WI, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.