FDA (Devices) recall action 97917
The FDA (Devices) publishes a recall like this one as 22 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 22 pages.
Potential issue where the IntelliVue monitors did not alarm.
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 North America is recalling the IntelliVue Patient Monitor MX400 over a potential issue where the monitors did not alarm.
Philips Ultrasound is recalling 4,819 Lumify Diagnostic Ultrasound Systems because compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imaging.
Get Tested International AB is recalling 258 units of its HPV Antigen Test because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue MP90 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP20 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP30 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX700 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP40 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP60 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX500 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 23 units of its Mycoplasma test, IgG and IgM because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue Patient Monitor MX800 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Multi Measurement Server X2 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX750 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 12 units of its Peptic Ulcer Test (H. pylori) because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue Patient Monitor MX600 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP80 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 17 units of its DHEA Test because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue MP50 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP5 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP70 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX850 over a potential issue where the monitors did not alarm.