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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 136 04 13 001
Date submitted: 6/28/2015
Manufacturer:BrainLAB
Device Type:Brainlab Cranial Navigation System
Description:Brainlab Cranial Navigation System
Medical Device Identifier:Brainlab Cranial Navigation System (all versions)
Reason of Field Safety Corrective Action:Brainlab has detected that, when using the Brainlab Cranial Navigation System, the following: may have a significant effect on the overall navigation accuracy: • Large distance between reference array and region of interest • Major changes of the camera position relative to the reference array during the Procedure. Those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure.
Remedy Action:In the Appendix of this Product Notification you find the document (attached) (“Measures to Improve Cranial Navigation Accuracy”, supplementing the current User Manuals. This document contains the relevant information regarding user corrective actions related to the above-described effect. Further, the document reiterates the information already described in the User Manuals, additionally including more detailed descriptions of the relevant measures to improve the overall navigation accuracy.

…………………………….

,b> TGA update action :

Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrage for the installation of the update.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00558-1
Source Ref. Number:RC-2015-RN-00558-1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments