—#160720

Product

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

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K171801
Affected lot / code info: Serial Numbers for use in U.S.A.: JMX2030Y2B8 JMX2030Y2CR JMX2030Y2BN JMX2030Y2AY JMX2040Y2NZ JMX2022Y1U4 JMX2040Y2NU JMX2045Y2L0 JMX2030Y2D9 JMX2030Y2B1 JMX2035Y0XC JMX2035Y0XT JMX2030Y2DY JMX2035Y0XA JMX2040Y2R2 JMX2031Y0EV JMX2039Y1FZ JMX2030Y2BT JMX2030Y2EE JMX2030Y2DM JMX194840WA JMX2014419Y JMX201441AB JMX201441A4 JMX2014Z155 JMX2014Z15C JMX2014Z15L JMX2039Y1H7 JMX2039Y1H5 JMX2039Y1HR JMX2039Y1JM JMX2022Y194 JMX2018Z009 JMX2022Y15F JMX2040Y2QP JMX2030Y2PZ JMX2045Y2E4 JMX20184033 JMX2030Y2A8 JMX2039Y1GB JMX2040Y2P9 JMX2030Y2E6 JMX2030Y2EG JMX2022Y181 JMX2022Y1A7 JMX2040Y2QW JMX2030Y2B6

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2017-10-05
Posted by FDA: 2018-03-03
Terminated: 2019-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.