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

FDA Device Recall #Z-0850-2018 — Class II — October 5, 2017

Recall Summary

Recall Number Z-0850-2018
Classification Class II — Moderate risk
Date Initiated October 5, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Electronics North America Corporation
Location Andover, MA
Product Type Devices
Quantity 332 units

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.

Distribution Pattern

US Nationwide

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.