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Neurological Stereotaxic Instrument
FDA product code HAW · Class 2 · Neurology
5,249
Registered devices
42,962
Adverse events
201
Recalls
425
510(k) clearances
Devices with this code
Instr. Adapter Array (Starlink), Size M — Brainlab SENaviNetics Key Placement Guide Kit — Navinetics, Inc.AESCULAP — Aesculap AGNVM5 — Nuvasive, Inc.microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.Leksell Stereotactic System — Elekta Instrument ABAxiEM™ — MEDTRONIC NAVIGATION, INC.NA — Stryker Leibinger GmbH & Co. KGCompass International — Compass InternationalPULSE — Nuvasive, Inc.Solera — MEDTRONIC NAVIGATION, INC.SA Reduction Tube, 10 pack — MAZOR ROBOTICS LTDSOLERA — MEDTRONIC NAVIGATION, INC.NVM5 — Nuvasive, Inc.N/A — MEDTRONIC NAVIGATION, INC.Instr Adapt Clamp (Starlink), Size M — Brainlab SEN/A — inomed Medizintechnik GmbHmicroTargeting™ Insertion Tube Set — FHC, INC.N/A — MEDTRONIC NAVIGATION, INC.STar™ Drive MA System — FHC, INC.SA Reduction Tube — MAZOR ROBOTICS LTDSEEG SST DRILL ADAPTOR Ø2.45MM — MEDTECHmicroTargeting™ Electrode Insertion Tube Set — FHC, INC.NA — Sinovation (Beijing) Medical Technology Co., Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Medtronic Navigation, Inc. | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and |
| 2026-08-31 | Medtronic Navigation, Inc. | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and |
| 2026-08-31 | Medtronic Navigation, Inc. | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and |
| 2026-08-31 | Medtronic Navigation, Inc. | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and |
| 2026-03-19 | Elekta, Inc. | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| 2025-11-12 | Howmedica Osteonics Corp. | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application |
| 2025-09-30 | Elekta, Inc. | 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 |
| 2024-10-04 | FHC, Inc. | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long rela |
| 2024-09-25 | Elekta Instrument AB | 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 sta |
| 2024-03-26 | Medtronic Navigation, Inc. | 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 na |
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