IntelliVue X3 Patient Monitor.
Reported: April 18, 2018 Initiated: November 17, 2017 #Z-1315-2018
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.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 975 (updated 8-14-18)
- Distribution
- 48 Foreign Accounts
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
IntelliVue X3 Patient Monitor.. Recalled by Philips Electronics North America Corporation. Units affected: 975 (updated 8-14-18).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1315-2018.
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