Lower riskMedical device recall · FDA · Published August 31, 2018
Ashland Box Film Ball Cube II EBT3: Calibration Film May Cause Positional Inaccuracy
Ashland Box Film Ball Cube II EBT3 calibration film (P/N 027863-002 rev E) sold between Aug 2017-July 2018 may cause up to 0.5mm positional error in CyberKnife systems. Affected units should be checked for model and serial number.
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
Take action
Contact the company
📍Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
✎ GovInfoNow plain-language explainer
Ashland's Box Film Ball Cube II EBT3 calibration film (model P/N 027863-002 rev E) was recalled because it may cause up to 0.5mm positional inaccuracy in CyberKnife radiation therapy systems. This could affect treatment precision for cancer patients using the CyberKnife system. Read more at govinfonow.com/recall/69923-ashland-box-film-ball-cube-ii-ebt3-calibration-film-may.
“Ashland Box Film Ball Cube II EBT3: Calibration Film May Cause Positional Inaccuracy.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69923-ashland-box-film-ball-cube-ii-ebt3-calibration-film-may. Based on FDA recall #Z-3211-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3211-2018%22&limit=1).
The FDA announced on August 31, 2018, that Accuray Incorporated is recalling Ashland(TM) Box Film Ball Cube II EBT3 calibration film for CyberKnife systems. The product may introduce up to 0.5 mm of positional inaccuracy due to manufacturing dimensions not meeting specifications.
How to tell if you have it
Brand: Ashland
Product: Box Film Ball Cube II EBT3
Part Number: 027863-002 rev E
Distribution period: August 1, 2017 to July 31, 2018
Units affected: 259
The hazard
The Ball Cube II phantom calibration film was not manufactured within necessary dimensions. This defect may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System.
Context
GovInfoNow's records show Accuray Incorporated has 9 other recalls on record since November 17, 2017. Other recent recalls of similar products include Zeiss Intrabeam Spherical Applicator 1.5 cm Recall: Manufacturing Defect (June 1, 2026), Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (February 6, 2026), and Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (February 6, 2026).
How to tell if you have this one
Check for the Ashland brand on the film. The product was sold between August 1, 2017 and July 31, 2018. The model number is P/N 027863-002 rev E.
Brand
Ashland
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number and serial number to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall states the film may cause up to 0.5mm positional inaccuracy in CyberKnife systems, but it does not indicate a risk of injury or serious harm.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3211-2018 (August 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3211-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.