Company:Philips Electronics North America Corporation
Date of Enforcement Report 4/18/2018
Class lI:

PRODUCT

IntelliVue X3 Patient Monitor..
Recall Number Z-1315-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 11/17/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
968

DISTRIBUTION
48 Foreign Accounts

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