41 results
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Sources: EU EUDAMED, US FDA
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VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Recall
Completed
·Luminex Corporation·Product code PEN·April 16, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Enforcement
Class II
·Completed·Luminex Corporation·June 11, 2025
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
FDA Recall
Completed
·GE Healthcare, LLC·Product code LLZ·November 9, 2018
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.
FDA Recall
Completed
·Hycor Biomedical Inc·Product code DHR·February 21, 2018
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.
FDA Enforcement
Class II
·Completed·Hycor Biomedical Inc·August 7, 2019
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
FDA Enforcement
Class II
·Completed·Obalon Therapeutics Inc·May 6, 2020
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021