Data Foundry

Medical device recalls 2018

Intellivue iX Information Center Software — Class II medical device recall Z-0776-2018

Terminated recall by Philips Electronics North America Corporation, reported 2018-03-07. Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform pa

Recall numberZ-0776-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Electronics North America Corporation, Andover, MA, United States
Recall initiated2018-01-03
Classified2018-02-28
Reported by FDA2018-03-07
Terminated2019-11-14
Quantity20,357

Product

Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0

Reason for recall

Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.

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-0776-2018. 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.