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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac Dynamic Software

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  Class 2 Device Recall ExacTrac Dynamic Software see related information
Date Initiated by Firm May 14, 2021
Create Date June 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-1846-2021
Recall Event ID 87984
510(K)Number K203173  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Code Information Version 1.02, GTIN 04056481142315
Recalling Firm/
Manufacturer
Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall
Display of potential patient movement might be delayed to the user for high dose treatments.
FDA Determined
Cause 2
Software design
Action An Urgent Field Safety Notice/Product Notification dated 4/29/2021 was issued on 5/14/2021 via email explaining the safety issue and letting the customer know that this issue is in addition to the previous notification of 9/8/2020 which has now expanded to versions 1.0.1 and 1.0.2.
Quantity in Commerce 22 systems in the U.S.
Distribution US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military 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 = IYE and Original Applicant = Brainlab AG
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