352 results
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19ms
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Sources: EU EUDAMED, US FDA
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
FDA Recall
Open, Classified
·Product code OJH·November 26, 2025
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·February 18, 2022
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·February 18, 2022
Ingenia 3.0T, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
Achieva 3.0T, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code LNH·June 14, 2024
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code LNH·June 14, 2024
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code LNH·June 14, 2024
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·June 4, 2021
SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·June 4, 2021
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·June 4, 2021
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·December 23, 2021