Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Best Theratronics cabinet xray systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Best Theratronics cabinet xray systemssee related information
Date Initiated by FirmMay 06, 2016
Date PostedJuly 22, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall NumberZ-2251-2016
Recall Event ID 74637
Product Classification Irradiator, blood to prevent graft versus host disease - Product Code MOT
ProductBest 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.
Code Information All Raycell units with serial #'s 5000 and higher.  
FEI Number 3006946288
Recalling Firm/
Manufacturer		 BEST THERATRONICS LTD.
413 MARCH ROAD
KANATA Canada
For Additional Information ContactMike de van der Schueren
866-792-8598
Manufacturer Reason
for Recall		It was discovered that both the new device and the predicate device failed to comply with performance standard.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionBest 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 Commerce128
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-