FDA recall Z-1315-2018

Product

IntelliVue X3 Patient Monitor.

Reason for recall

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.

Distribution

48 Foreign Accounts

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-04-18

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2018