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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac Dynamic

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  Class 2 Device Recall ExacTrac Dynamic see related information
Date Initiated by Firm March 01, 2021
Create Date March 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-1185-2021
Recall Event ID 87395
510(K)Number K201276  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Code Information Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.
Recalling Firm/
Manufacturer
Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
FDA Determined
Cause 2
Software design
Action The Field Safety Notice / Product Notification Letter CAPA-20210210-002387 was distributed via email on 03/01/2021. An active reply by the consignees will be followed, if necessary via further different communication media. For future customers/facilities/systems (new installations or updates/upgrades): As of February 23, 2021: - the Field Safety Notice / product notification information is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a confirmation is required that the contained User Corrective Actions will be implemented before clinical use by the facility (to be adhered to by the users).
Quantity in Commerce 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Distribution USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
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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