133 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·August 20, 2013
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 8, 2019
Stryker Trio Mobile Surgery Platform; Model 1033.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FSE·May 15, 2006
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Recall
Terminated
·Philips North America, LLC·Product code HGP·January 25, 2019
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KEY·September 6, 2007
Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·May 11, 2009
Brilliance iCT Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 13, 2015
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·February 24, 2017
Ingenia 3.0T-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 Number: 781342
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia Elition S-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 Number: 781357 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Achieva 3.0T-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 Number: 781277 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia CX 3.0T-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 Number: 78127 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia 1.5T-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 Number: 781341
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia 1.5T Evoluton- 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 Number: 781315
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia Elition 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 Model Number: 781358
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Recall
Terminated
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·October 4, 2016