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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 010 08 18 000
Date submitted: 8/2/2018
Manufacturer:Ethicon Inc.
Device Type:ETHICON Generator Gen11
Description:cybersecurity software
Medical Device Identifier:All
Reason of Field Safety Corrective Action:Ethicon Endo-Surgery, LLC (Ethicon) has confirmed a cybersecurity software vulnerability on your Ethicon Generator Gen11 (Gen11) and is issuing a field cybersecurity routine update and patch to address that cybersecurity software vulnerability to your Gen11. This cybersecurity software vulnerability can exist when using the Gen11 system with certain non-OEM disposable devices (as defined below) as it is possible for these devices to bypass the Gen11 security authentication.
Remedy Action:1.Examine your inventory to determine if you have any Ethicon Gen11 Generators. The Product Identification Tool in Attachment 1 can be used to identify Ethicon Gen11 Generators.

2.Please complete the Business Reply Form (Attachment 2) and fax or email it to [Affiliate Phone number and email address]] within five (5) business days. Please return the BRF even if you do not have an Ethicon Gen11 Generator. a.Customers who respond that they have Ethicon Gen11 Generator(s) to be updated will be contacted by their Ethicon sales representative to schedule the update for their generator.

3.Keep this notice visibly posted for awareness until all Ethicon Gen11 Generators at your facility have been upgraded.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Saudi Arabia Limited
Report Source:NCMDR
Source Ref. Number:B939D140B92BC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Ethicon Inc.pdf