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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 089 10 18 000
Date submitted: 10/17/2018
Manufacturer:Medtronic
Device Type:CareLink 2090 and CareLink Encore 29901/29901A Programmers
Description:Pacemaker programmer
Medical Device Identifier:CareLink 2090 Programmer - All Serial Numbers
CareLink Encore 29901/29901A Programmer - All Serial Numbers
Reason of Field Safety Corrective Action:Medtronic is writing to inform you of a modification we are making to improve cybersecurity of device programmers by changing how the programmers are updated with new software. Currently, the Medtronic CareLink™ 2090 and CareLink Encore™ 29901 programmers receive new software from one of two routes: using the USB port or using a network connection via the Software Distribution Network, or SDN. The SDN is a worldwide network that allows the download of new or updated software to the CareLink 2090 and CareLink Encore 29901 Programmers via the internet. Beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method. If you currently use the USB updating process, there will be no change to your workflow.
Remedy Action:Medtronic is advising customers that beginning 11 October 2018, the SDN will be disabled for programmer updates. Updates will rely solely on the USB update method. For users who currently utilise the USB updating process there will be no change to the workflow.
Kindlly, follow the recommendations in the attached FSN.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:EEA8BE480B2A7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf