Recall Z-1315-2018— Philips Electronics North America Corporation

Name: FDA recall Z-1315-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-11-17, terminated 2020-09-16. It names one FDA 510(k) clearance: K171801. Product: IntelliVue X3 Patient Monitor.. 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: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Terminated: 2020-09-16
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K171801 — IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 +2 morePhilips Medizin Systeme Boeblingen GmbH·cleared 2017-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.