Reported Sep 26, 2018 · Terminated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
- Ashland(TM) Box Film Ball Cube II EBT3
- P/N027863-002 rev E Product is used to calibrate CyberKnife systems
- Lot codes and dates
- All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
- Amount recalled
- 259 units
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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