Ultrasound Navigation
Brainlab SE · Model 1.2 · UDI-DI 04056481144630
Description
Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by: - Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.). - Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Stryker Leibinger GmbH & Co. KG | Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient. |
| 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 track the spheres. |
| 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 track the spheres. |
| 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 track the spheres. |
| 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 track the spheres. |
| 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" resulting in an in |
| 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 wound |
| 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 relative to the size of |
| 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 stainless steel, same m |
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