Allergy test Small
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Class I - Dangerous
Distribution without premarket approval/clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Peptic Ulcer Test (H, pylori)
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Class I - Dangerous
Distribution without premarket approval/clearance.
Heavy Metals Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Philips North America
Class I - Dangerous
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Fructose Intolerance Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Trichomonas Vaginalis test
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP50. Product Number: M8004A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
SIBO Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP80. Product Number: M8008A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue Patient Monitor MX100. Product Number: 867033.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Intestinal Worms Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
D-Dimer Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP40. Product Number: M8003A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Diabetes HbA1c Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Olympus OER-Elite
Aizu Olympus Co.
Class I - Dangerous
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Candida Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Syphilis Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Iodine Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
MPOX Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Class I - Dangerous
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.