FDA recall Z-0850-2018

Philips Electronics North America Corporation · Class II · device

Product

Philips Network Firewall (Cisco ASA 5506), Model # 867098

Reason for recall

Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. 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 not recoverable. This failure will result in loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot.

Distribution

US Nationwide

Key facts

Status: Terminated
Initiation date: 2017-10-05
Report date: 2018-03-14
Termination date: 2019-07-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0850-2018