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 Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.
Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.