FDA-Device2018-04-18Class II
IntelliVue X3 Patient Monitor.
Philips Electronics North America Corporation
Hazard
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.
Sold states
48 Foreign Accounts
Affected count
975 (updated 8-14-18)
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
IntelliVue X3 Patient Monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2018Don't want to check this manually?
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