Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy
Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may introduce positional inaccuracy into radiation therapy systems. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 259 units of the Ashland Box Film Ball Cube II EBT3 (P/N: 027863-002 rev E). This product is used to calibrate CyberKnife radiation therapy systems. The recall covers all units with the Ashland brand distributed between August 1, 2017, and July 31, 2018.
The recall was initiated because the calibration film was not manufactured within necessary dimensions. This defect may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System. The affected units were distributed worldwide, including in the United States, United Kingdom, Germany, France, Finland, Netherlands, Portugal, Hong Kong, Poland, Australia, United Arab Emirates, Thailand, and Japan.
Healthcare facilities and users of these calibration phantoms should stop using the affected units and contact Accuray Incorporated for instructions on how to return or replace the product.
The recalled product
- Product
- Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
- Manufacturer
- Accuray Incorporated
- Affected units
- 259
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All units with the Ashland Brand distributed between August 1
- 2017 and July 31
- 2018
Distribution
Distributed nationwide across the United States.
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