• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Linear Accelerator

  • 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 Linear Acceleratorsee related information
Date Initiated by FirmApril 19, 2012
Date PostedMay 23, 2012
Recall Status1 Terminated 3 on October 06, 2014
Recall NumberZ-1651-2012
Recall Event ID 61812
510(K)NumberK082122 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMLCi/MCLi2. Radiation therapy.
Code Information MRT 2424/MRT 14401
Recalling Firm/
Manufacturer
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas Valentine
770-670-2548
Manufacturer Reason
for Recall
The Y2 diaphragm block was found loose.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionElekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
Quantity in Commerce386
DistributionNationwide Distribution including Puerto Rico.
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.
510(K) Database510(K)s with Product Code = IYE
-
-