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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 Dynamicsee related information
Date Initiated by FirmMarch 01, 2021
Create DateMarch 08, 2021
Recall Status1 Terminated 3 on March 20, 2023
Recall NumberZ-1185-2021
Recall Event ID 87395
510(K)NumberK201276 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductExacTrac 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
ActionThe 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 Commerce73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
DistributionUSA: (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 CycleTPLC 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) Database510(K)s with Product Code = IYE
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