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

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


New Search Back to Search Results
 Class 2 Recall
Monaco RTP System		see related information
Date Posted February 20, 2013
Recall Number Z-0841-2013
Product Monaco RTP System. Radiation treatment planning.
Code Information Versions 3.20.00 and 3.20.01
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta, Georgia 30346-1227
Consumer Instructions No consumer action necessary
For Additional Information Contact Chris Ivicevich
408-830-8023
Reason for
Recall		 The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Action Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
Quantity in Commerce 13
Distribution Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
 
-
-