Philips Electronics North America Corporation recalls Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center…

Recall date

January 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0776-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Domestic and Foreign

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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