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[Recalled] Philips IntelliVue Measurement Module X1 Model: M3001A — The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Modu… | FDA 2016-01-04

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductPhilips IntelliVue Measurement Module X1 Model: M3001A
Brand / manufacturerPhilips Electronics North America Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0853-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date04 January 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Philips Electronics North America Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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