FDA (Devices) recall action 80064
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Five warning statements are missing from the instructions for use.
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 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
Philips is recalling 7,178 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.