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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- 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

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

FDA Recall
Terminated ·Philips North America Llc·Product code JAK·June 8, 2021

728332 IQon Spectral CT-Computed Tomography X-ray system

FDA Recall
Terminated ·Philips North America Llc·Product code JAK·June 8, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·May 1, 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

Infant Heel Warmers w/strap, Reference # 989805603201 1223

FDA Recall
Open, Classified ·Philips North America Llc·Product code IMD·November 29, 2021

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

FDA Recall
Open, Classified ·Philips North America Llc·Product code IMD·November 29, 2021

Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.

FDA Recall
Terminated ·Philips North America Llc·Product code MWI·February 22, 2022

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

FDA Recall
Open, Classified ·Philips North America Llc·Product code KPR·September 21, 2023

The Oncology Essentials Package of the Spectral CT imaging system.

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·March 29, 2024

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