BEST THERATRONICS LTD.: Medical Device Recall in 2016 - (Recall #: Z-2251-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 6, 2016

Date Posted: August 3, 2016

Recall Number: Z-2251-2016

Event ID: 74637

Reason for Recall:

It was discovered that both the new device and the predicate device failed to comply with performance standard.

Status: Terminated

Product Quantity: 128

Code Information:

All Raycell units with serial #'s 5000 and higher.

Distribution Pattern:

Nationwide

Voluntary or Mandated:

FDA Mandated