Philips Electronics North America Corporation recalls IntelliVue X3 Patient Monitor.

Recall date

November 17, 2017

Source

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

Recall number

Z-1315-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

48 Foreign Accounts

Why it was recalled

The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.

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 X3 Patient Monitor.