56 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code LDF·April 21, 2026
Leksell Gamma Knife C
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·August 1, 2006
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·November 9, 2008
Philips Zenition 50, Model Number: 718096
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·October 7, 2024
Philips Zenition 70, Model Number: 718133
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·October 7, 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
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
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 1.5T S Model Number (REF): 781347
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024