47 results · 10ms · Sources: EU EUDAMED, US FDA

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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

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

Achieva 1.5T Initial system. Model (REF) Numbers 781178.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024