IBS Test
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Medical equipment, implants, and diagnostic devices
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).