Best Theratronics cabinet x-ray systems intended for use in the… — Class II medical device recall Z-2251-2016
Terminated recall by BEST THERATRONICS LTD., reported 2016-08-03, distributed nationwide. It was discovered that both the new device and the predicate device failed to comply with performance standard
| Recall number | Z-2251-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | BEST THERATRONICS LTD., KANATA, N/A, Canada |
| Recall initiated | 2016-05-06 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 128 |
| Serial numbers | 5000 |
Product
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Reason for recall
It was discovered that both the new device and the predicate device failed to comply with performance standard.
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-2251-2016. 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.