# FDA recall Z-3211-2018

> **Accuray Incorporated** · Class II · device recall initiated 2018-08-31.

## Product

Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E     Product is used to calibrate CyberKnife systems

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-3211-2018
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-31
- **Report date:** 2018-09-26
- **Termination date:** 2020-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3211-2018

## Citation

> AI Analytics. FDA recall Z-3211-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-3211-2018. Source: US FDA. Licensed CC0.

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