[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Philips IntelliVue Measurement Module X1 Model: M3001A |
|---|---|
| Brand / manufacturer | Philips Electronics North America Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0853-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 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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