Data Foundry

Medical device recalls 2018

Philips Network Firewall — Class II medical device recall Z-0850-2018

Terminated recall by Philips Electronics North America Corporation, reported 2018-03-14, distributed nationwide. Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defe

Recall numberZ-0850-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Electronics North America Corporation, Andover, MA, United States
Recall initiated2017-10-05
Classified2018-03-02
Reported by FDA2018-03-14
Terminated2019-07-01
DistributedNationwide (US)
Quantity332 units
Serial numbersJMX194840WA, JMX2014419Y, JMX201441A4, JMX201441AB, JMX2014Z155, JMX2014Z15C, JMX2014Z15L, JMX20184033, JMX2018Z009, JMX2022Y15F, JMX2022Y181, JMX2022Y194, JMX2022Y1A7, JMX2022Y1U4, JMX2030Y2A8, JMX2030Y2AY, JMX2030Y2B1, JMX2030Y2B6, JMX2030Y2B8, JMX2030Y2BN, JMX2030Y2BT, JMX2030Y2CR, JMX2030Y2D9, JMX2030Y2DM, JMX2030Y2DY and 22 more
Model numbers867098

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0850-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.