206 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
FDA Recall
Terminated
·Elekta, Inc.·Product code HAW·October 2, 2009
Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc·Product code HAW·December 22, 2010
Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012
ENT PRGM 9734636 ADD FUSION NAV AxiEM
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
DISP 9730950 STRL SPHERE, 1 PK INSERT
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HAW·May 13, 2014
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·May 5, 2015
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
FDA Recall
Terminated
·Mazor Robotics Ltd·Product code HAW·November 26, 2014
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
FDA Recall
Open, Classified
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·September 25, 2024
PIN, 9733235, 100MM, STERILE, PERC REF
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
TUMOR RES. PACK 9733553 AxiEM S.M.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
SHUNT KIT 9733605 NON-INVASIVE
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
DISP 9730951 STRL SPHERE, 5PK INSERT
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
KIT, 9731427, THORACIC TACTILE PROBES
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
TUMOR RESECTION KIT 9733608 SKULL MOUNT
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
TUMOR RESECTION KIT 9733607 NON-INVASIVE
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014