Recall Z-0850-2018— Philips Electronics North America Corporation

Name: FDA recall Z-0850-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-05

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-10-05, terminated 2019-07-01. It names one FDA 510(k) clearance: K171801. Product: Philips Network Firewall (Cisco ASA 5506), Model # 867098. Reason: 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..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-10-05
Terminated: 2019-07-01
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K171801 — IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 +2 morePhilips Medizin Systeme Boeblingen GmbH·cleared 2017-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.