Ashland — Class II medical device recall Z-3211-2018
Terminated recall by Accuray Incorporated, reported 2018-09-26, distributed nationwide. the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce u
| Recall number | Z-3211-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2018-08-31 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, DE, FI, FR, GB, HK, JP, NL, PL, PT, TH |
| Quantity | 259 units |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3211-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.