BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navi
FDA device recall Z-0470-2019 · posted 2018-11-26 · Terminated
Recall details
- Recalling firm
- Synaptive Medical Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 37 units
- Distribution
- Worldwide - US Nationwide Distribution and the country of Canada
- Date initiated
- 2018-10-09
- Date posted
- 2018-11-26
- Date terminated
- 2021-08-12
- Location
- Toronto, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BrightMatter Guide with Surface Trace Registration (K153281) | Synaptive Medical, Inc. | 2016-03-30 |