IntelliVue Patient Monitor MX800. Product Number: 865240.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
HPV Antigen Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound
Class I - Dangerous
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Sperm Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Mycoplasma test, IgG and IgM
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Parasite Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Adrenal Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Pollen Allergy Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Alcohol (ALC) Test Saliva
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test XL
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Pet Allergy Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX700. Product Number: 865241.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Urinary Tract Infection Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX500. Product Number: 866064.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Lactose Intolerance Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
PSA Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX850. Product Number: 866470.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Gut Microbiome Test Small
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
8 in 1 STI Test Kit
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Akkermansia Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.