9 results
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60ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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OEC Elite Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC 9900 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024