FDA Device recall Z-2251-2016
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to i…
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to i… by Best Theratronics, citing it was discovered that both the new device and the predicate device failed to comply with performance standard.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2251-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-06 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Best Theratronics |
| Distribution | US |
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
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Identifiers
| code_info | All Raycell units with serial #'s 5000 and higher. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2251-2016%22
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