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U.S. Department of Health and Human Services

Class 2 Device Recall Oncentra Brachy

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  Class 2 Device Recall Oncentra Brachy see related information
Date Initiated by Firm December 05, 2022
Date Posted December 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0719-2023
Recall Event ID 91224
510(K)Number K132816  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Oncentra Brachy radiation therapy planning system software.
Code Information Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Elekta help desk
855-693-5358
Manufacturer Reason
for Recall		 A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
FDA Determined
Cause 2		 Software design
Action Elekta issued an Important Field Safety Notice 806-01-BTP-003 dated November 2022 to all affected customers on 12/5/2022 via email. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice is to be posted in a place accessible to all users until this action is closed. Appropriate personnel working with the product are to be advised of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no longer than 30 days from receipt. Update: The manufacturer has now released the solution to this issue for affected Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00. All affected customers will receive a software update in order to solve the issue. The solution was released for installation in the field on 20-MAR-23. Customers are being notified by email on 03/20/2023. Customers are being informed that the fix is available for download/request depending on their standard processes. Elekta service teams will pro-actively follow up with customers to insure the fix has been installed before the target completion date.
Quantity in Commerce 336 systems
Distribution Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = NUCLETRON B.V.
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