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
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.
The calibration film was manufactured with dimensions that may be slightly off, causing up to 0.5mm positional error in the CyberKnife system. This could lead to less precise radiation targeting during cancer treatment.
Patients receiving CyberKnife radiation therapy using this calibration film may be affected. Medical professionals who use the film for treatment calibration are most at risk.
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.
Identify the model number and serial number to confirm if your unit is affected.
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.
Check for the Ashland brand on the film. The product was sold between August 1, 2017 and July 31, 2018 with model number P/N 027863-002 rev E.
The recall does not specify a remedy, so you should check with your healthcare provider or CyberKnife facility to determine if the film needs replacement.
We’ve drafted a message you can send Ashland to request your refund or repair — edit it as you like.
Subject: Recall Z-3211-2018 — Ashland Ashland Hello, I own a Ashland that is covered by recall Z-3211-2018 from Ashland. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.