Product Wiki · Recalls · U.S. FDA — Device Enforcement

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

U.S. FDA — Device Enforcement · United States · 2017-11-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1315-2018
Date of alert
2017-11-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Electronics North America Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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