Best Theratronics cabinet x-ray systems intended for recall
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate…
Why was Best Theratronics cabinet x-ray systems intended for recalled?
It was discovered that both the new device and the predicate device failed to comply with performance standard.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Raycell units with serial #'s 5000 and higher.
- Product
- Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate…
- Recalling firm
- BEST THERATRONICS LTD.
- Quantity
- 128
- Distribution
- Nationwide
- Recall date
- August 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)