Neurological Devices

Neurological Devices

3D, lots C00644, C00645, C00646, C00717.

Neurological Devices

For use in the revascularization of patients with acute ischemic stroke.

Doro Lucent - 1101.021, 1101.031, 1101.026

Neurological Devices

Neurological Devices

Shunt for treatment of hydrocephalus

Model: Model: 3389, Affected: All lots

Neurological Devices

Model: Model: 3387, Affected: All lots

Neurological Devices

Model: Model: 3391, Affected: All lots

Neurological Devices

Model: , Affected: 42955, STRATAMR VALVE, SMALL - E06139, 42965, STRATAMR VALVE, REGULAR - E06016, E06138

Neurological Devices

Neurological Devices

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Neurological Devices

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Neurological Devices

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Neurological Devices

Neurological Devices

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Neurological Devices

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Neurological Devices

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Neurological Devices

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Neurological Devices

medical_device

Style STE00059FG and Style STE00118FG

Neurological Devices

1

No

Nationwide.

Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

EPWorks Software Versions prior to 6.0

Neurological Devices

2

No

US Nationwide Distribution

EPWorks software used in the Protektor 32 || Product Usage: || Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

EPWorks Software Versions prior to 6.0

Neurological Devices

2

No

US Nationwide Distribution

EPWorks software used in the Xltek Protektor Stimulator || Product Usage: || Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Neurological Devices

2

No

US Distribution to the states of: NC and CA., and Internationally to Switzerland.

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967, 100944, 100941, 100945, 100970, 100950, 100976, 100951, 100728, 100952, 100248, 100953, 100641, 100954, 100463, 100955, 100981, 100957, 100978, 100958, 100106, 100959, 100939, 100960, 100973, 100961, 100236, 100962, 100237, 100963, 100417, 100964. 100940, 100968, 100975, 100969, 100977, 100972, 100105, 100974, 100214, 100980, 100492, 100982, 100493, 100983, 100948, 100986, 100704, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942.

Neurological Devices

2

No

Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.

Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U || Product Usage: || The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

Model/catalogue numbers: 19060 AIR ICT S&T; W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)

Neurological Devices

2

No

Distributed in the US and Australia.

BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

lot number 150223

Neurological Devices

2

No

US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.

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.