76 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
FDA Recall
Open, Classified
·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
FDA Recall
Open, Classified
·BioFire Diagnostics, LLC·Product code QBH·May 8, 2023
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code QBH·April 16, 2021
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code QBH·June 7, 2021
Intera 0.5T Standard, Model Number: 781101;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T Omni/Stellar, Model Number: 781104;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T Master/Nova, Model Number: 781106;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Enterprise 1.5T, Model Number: 781145;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T, Model Numbers: 781195 and 781295;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.0T Omni/Stellar, Model Number: 781102;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.0T Power/Pulsar, Model Number: 781103;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 3.0T Quasar Dual, Model Number: 781150;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
SmartPath to dStream for 1.5T, Model Number: 782146;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera CV, Model Number: 781107;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T R11, Model Number: 781170;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Intera 1.5T Power/Pulsar, Model Number: 781105;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
SmartPath to dStream for 3.0T, Model Number: 782145;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Achieva XR. Model (REF) Numbers 781153, 781253.
FDA Recall
Open, Classified
·Philips North America·Product code LNI·January 3, 2024
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
FDA Recall
Open, Classified
·Philips North America·Product code LNI·January 3, 2024