Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0850-2018 · Posted 2018-03-03

Recall StatusTerminated
Product CodeMHX
Date Initiated2017-10-05
Date Terminated2019-07-01
Product Quantity332 units

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.

Firm Action

Philips sent an Urgent Recall Notice letter dated October 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a Philips representatives will contact affected customers to arrange for replacement of all affected units supplied by Philips. For questions contact your local Philips representative: Philips Customer Care Solution Center 800-722-9377.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑