45 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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BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·October 5, 2009
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 22, 2017
CR DX-S, DX-S, Computed radiography system (Digitizer)
FDA Recall
Terminated
·AGFA Corp.·Product code MQB·November 3, 2005
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HWC·January 10, 2017
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 1, 2014
Villa Sistemi Rotograph EVO 3D X-ray
FDA Enforcement
Class II
·Terminated·Villa Radiology Systems LLC·November 18, 2015
Owandy Radiology I -MAX Touch 3D X-ray
FDA Enforcement
Class II
·Terminated·Villa Radiology Systems LLC·November 18, 2015
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
FDA Recall
Terminated
·Product code LLZ·November 29, 2013
Villa Sistemi Rotograph EVO 3D X-ray
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code MUH·August 5, 2015
Owandy Radiology I -MAX Touch 3D X-ray
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code OAS·August 5, 2015
Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
FDA Recall
Terminated
·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
FDA Enforcement
Class II
·Terminated·L3 Security & Detection·January 3, 2018
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·December 3, 2014
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
FDA Recall
Terminated
·Product code RCG·October 27, 2017
Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images.
FDA Recall
Terminated
·Eos Imaging 10, Rue Mercoeur Paris France·Product code LLZ·April 13, 2011
Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
FDA Recall
Terminated
·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008
Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
FDA Recall
Terminated
·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008
Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
FDA Recall
Terminated
·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014