FDA (Devices) recall action 72720
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
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 PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.
Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.
Philips is recalling IntelliVue Info Center iX software because reconstructed ECG leads may misrepresent waveforms in specific leads.