IntelliVue MP5. Product Number: M8105A.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
All Recalls
95,018 total recalls in our database
Organic acids Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP20. Product Number: M8001A.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Hair Mineral Analysis
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX600. Product Number: 865242.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Gut Microbiome Test Large
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Chlamydia Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Gonorrhea test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Cholesterol Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Iron Deficiency Test (ferritin)
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Thyroid TSH Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Herpes (HSV-1 & HSV-2) Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Iron Deficiency Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Diabetes Test (ketones & glucose)
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Liver Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX400. Product Number: 866060.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Pregnancy Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Allergy & Food Intolerance Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Ovulation Test (5 tests)
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.