FDA Medical Device Recalls (openFDA)
BEST THERATRONICS LTD.: 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.
- Recall number
- Z-2251-2016
- Recalling firm
- BEST THERATRONICS LTD.
- 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.
- Status
- Terminated
- Initiated
- 2016-05-06
- Posted
- 2016-07-22
- Terminated
- 2017-08-01
- Reason
- It was discovered that both the new device and the predicate device failed to comply with performance standard.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Best Theratronics ( BTL) planned action to bring into compliance: BTL proposes that the repairs are to be completed during annual routine preventive maintenance visits at the user's site to minimize downtime, which disrupts the user's ability to irradiate blood. A standard repair kit has been developed. For further information, please contact Best Theratronics Customer Service at 1-866-792-8598
- Quantity
- 128
- Distribution
- Nationwide
- Lot, serial or model codes
- All Raycell units with serial #'s 5000 and higher.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MOT
- Firm FEI
- 3006946288
- Firm city
- KANATA
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28