26 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Completed
·Accuray Incorporated·Product code IYE·December 23, 2024
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·February 5, 2025
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
SIGNA Voyager nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
Revolution CT
FDA Recall
Completed
·GE Healthcare, LLC·Product code JAK·March 19, 2021
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·May 24, 2018
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
SIGNA Architect nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
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
Discovery NM/CT 670 ES, model 5376204-70-57
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·May 24, 2018
VariCam
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
SIGNA Pioneer nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
Discovery NM/CT 670 Pro, model 5376204-70-54
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·May 24, 2018
SIGNA Premier nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
Optima MR450w 1.5T nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
FDA Recall
Completed
·GE Healthcare, LLC·Product code DQK·March 16, 2022
SIGNA Artist nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
Discovery MR750 3.0T nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021