Recall Z-0470-2019 ยท HAW Neurological Stereotaxic Instrument
Synaptive Medical Inc
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip exten
| Date | Nov 26, 2018 (initiated Oct 9, 2018) |
| Status | Terminated |
| Reason | This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure. |
| Root cause | Software design |
| Action | Synaptive Medical sent an Urgent Medical Device Recall letter dated October 9, 2018 via registered priority mail. The letter identified the affected product, problem and actions to be taken until a software patch is released. Customers were requested to complete and return the enclosed Acknowledgement and Receipt form to Synaptive Medical Inc. For questions call 1-844-462-7246. |
| Quantity | 37 units |
| Distribution | Worldwide - US Nationwide Distribution and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153281 | BrightMatter Guide with Surface Trace Registration Synaptive Medical, Inc., Mar 30, 2016 |