Neurological Stereotaxic Instrument

Brand Name: Leksell Vantage Arc System

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) a

When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

Brand Name: Leksell Stereotactic System

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereot

A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933,

Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in eith

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposa

Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.

Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.