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U.S. Department of Health and Human Services

Class 2 Device Recall Flexitron remotecontrolled radionuclide applicator system

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  Class 2 Device Recall Flexitron remotecontrolled radionuclide applicator system see related information
Date Initiated by Firm November 18, 2019
Create Date January 02, 2020
Recall Status1 Terminated 3 on March 28, 2023
Recall Number Z-0772-2020
Recall Event ID 84371
510(K)Number K070574  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
Code Information REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
Recalling Firm/
Manufacturer		 Nucletron BV
Waardgelder 1
POBox 930
Veenendaal Netherlands
Manufacturer Reason
for Recall		 A component failure may lead to treatment interruption or incorrect source positioning.
FDA Determined
Cause 2		 Process control
Action The recalling firm will send a Field Safety Notice 806-01-BTD-001 to all affected customers. The notice informs user of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. A copy of the Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are instructed to complete and return the Field Safety Notice Acknowledgement form to their local Eleka representative as soon as possible and no longer than 30 days from receipt.
Quantity in Commerce 383
Distribution Distribution in United States and worldwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = ISODOSE CONTROL B.V.
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