Recall Z-0056-2021 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. |
| Root cause | Software design |
| Action | The intraoperative Brainlab Ultrasound Navigation Software does not support the modification of the probes image width, an optional feature of the BK Medical Ultrasound System, resulting in an incorrect display of the depth of the ultrasound overlay by the navigation for non-linear ultrasound probes, with the deviation depending on the probe and the difference between the calibrated and used image width. |
| Quantity | 271 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED Brainlab AG, May 6, 2010 |