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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 016 10 17 000
Date submitted: 10/2/2017
Manufacturer:Philips Burton
Device Type:Philips Network, Cisco Adaptive Security Appliance (ASA) 5506 firewall
Description:Adaptive Security Appliance (ASA) 5506 firewall
Medical Device Identifier:Philips Network Firewall 867098 (Cisco ASA 5506 Firewall) used with the Philips IntelliVue Information Center iX or Classic Information Center.

Any appliance with a serial number less than JMX2050000 are affected.
Reason of Field Safety Corrective Action:The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal component were to fail, the firewall will stop functioning, will not boot, and is unable to recover from the component failure.
This failure will result in a loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot
Remedy Action:Philips representatives will contact affected customers to arrange for replacement of all affected units supplied by Philips.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:5E47B0D5792A3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips .pdf