FDA (Devices) recall action 73209
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.
Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.