3,061 results
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102ms
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Sources: EU EUDAMED, US FDA
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PHILIPS MEDICAL SYSTEMS, INC.
FDA Adverse Event
Other
·PHILIPS MEDICAL SYSTEMS, INC.·Product code JAK·March 9, 1998
Philips Medical Systems (Cleveland), Inc.
FDA registration
Philips Medical Systems (Cleveland), Inc.·3 products·🇺🇸 United States
Philips
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838091122·Pinnacle3 Radiation therapy treatment planning ...
Philips
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838098992·Pinnacle Radiation Therapy Planning System Vers...
Ingenuity Flex
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838059528·
Pinnacle Radiation Therapy Planning System
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838103566·
Philips
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838085602·Pinnacle Radiation Therapy Planning System Vers...
Pinnacle Radiation Therapy Planning System
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838102965·
Philips
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838074200·Pinnacle Radiation Therapy Planning System Vers...
Ingenuity TF
FDA UDI
Philips Medical Systems (cleveland), Inc.·00884838059443·
BRILLIANCE 64-SLICE
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.·Product code JAK·July 12, 2022
BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 15, 2011
BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 15, 2011
BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 15, 2011
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012
TELEHEALTH CENTER PRODUCT LICENSE
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code MSX·November 5, 2024
PRECISE SDS SELF EXPANDING
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·July 2, 2014
BRIGHTVIEW XTC IMAGING SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS, INC.·Product code KPS·June 29, 2010
BRIGHTVIEW IMAGING SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS, INC.·Product code KPS·June 29, 2010