Best Theratronics Cabinet X-Ray Systems Recalled for Performance Non-Compliance
Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. As no specific injuries or illnesses are reported in the source text, and the issue is a performance standard compliance failure rather than a direct acute hazard like a fire or pathogen, a Moderate severity is appropriate.
Plain-English summary
Best Theratronics Ltd. is recalling 128 cabinet x-ray systems intended for the irradiation of blood and blood products. These devices are used to inactivate T-lymphocytes in transfusion bags to prevent Graft Versus Host Disease. The recall covers all Raycell units with serial numbers 5000 and higher, which were distributed nationwide.
The recall was initiated because it was discovered that both the new device and the predicate device failed to comply with performance standards. The source text does not specify the exact nature of the performance failure or report any specific injuries or illnesses associated with the use of these devices.
Healthcare facilities and blood banks that possess these units should contact Best Theratronics Ltd. for instructions on how to proceed with the recall. Users should verify their equipment serial numbers to determine if they are affected.
The recalled product
- 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.
- Manufacturer
- BEST THERATRONICS LTD.
- Affected units
- 128
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 (1)
- All Raycell units with serial #'s 5000 and higher.
Distribution
Distributed nationwide across the United States.
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