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Philips Electronics North America Corporation recalls IntelliVue X3 Patient Monitor.
Recalled April 18, 2018 · FDA recall Z-1315-2018 · Philips Electronics North America
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. · FDA Class II
Units
975 (updated 8-14-18)
Sold at
48 Foreign Accounts
Description
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.
Product
IntelliVue X3 Patient Monitor.
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →