Ashland(TM) Box Film Ball Cube II EBT3 recall
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Why was Ashland(TM) Box Film Ball Cube II EBT3 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
- Product
- Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
- Recalling firm
- Accuray Incorporated
- Quantity
- 259 units
- Distribution
- 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.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)