Z-2251-2016Class II

Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products...

Name: Z-2251-2016 Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products...
Creator: Best Theratronics Ltd.
Published: 2016-05-06
License: https://open.fda.gov/license/

Best Theratronics Ltd. / initiated 2016-05-06 / Terminated

FDA source

BEST THERATRONICS LTD. began a recall of Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate... on 2016-05-06. FDA classified it as Class II and gives the reason as "It was discovered that both the new device and the predicate device failed to comply with performance standard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2251-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Posted: 2016-07-22
Terminated: 2017-08-01
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.
Product code: MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Reason for recall: It was discovered that both the new device and the predicate device failed to comply with performance standard.
FDA 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 in commerce: 128
Distribution: Nationwide
Product codes and lots: All Raycell units with serial #'s 5000 and higher.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2251-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2251-2016	Class II	Terminated	FDA Mandated	2016-08-03	2016-07-22

Product code MOT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)