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Terminated

IntelliVue X3 Patient Monitor.

FDA Recall Z-1315-2018 · Posted 2018-04-06

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMHX
Date Initiated2017-11-17
Date Terminated2020-09-16
Product Quantity975 (updated 8-14-18)

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.

Firm Action

Philips will contact customers with affected devices to arrange a correction of the issues. Firm plans a Software update of the affected devices and Replacement of the display assembly.

Root Cause

Under Investigation by firm

Distribution Pattern

48 Foreign Accounts

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP CablePhilips Medizin Systeme Boeblingen GmbH · 2017-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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