Reported Dec 5, 2018 · Terminated
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can…
Synaptive Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synaptive Medical Inc · 555 Richmond St West, Suite 800 · Toronto, N/A · N/A
Is this the product you have?
- BrightMatter Guide, Product Number SYN-0026
- Versions
1.5.01.5.1 and 1.5.2
- Product UsageBrightMatter 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 extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document
- Lot codes and dates
- Serial Numbers
0063HJ5Y06200635F4856200635GTYK3200638HTZK320063G6DRM120063CPBRM12006395Q2Z520063J9BD06200634X195620063GN0B56200637BP95620063JTDW46200638J89562006360JV4620063F1Q2Z520063FGWYK32006384WYK3200635YH85620063C2SKH7200635NWPK120063DKWYK32006358Q2Z520063HM0B5620063DZPGP1200634BBD06200636L485620063DD8GP120063HCZ1Z52006318XYK320003CZDRLC20063GLD65620063HRZYK32006317B8562006348M55620063HGTYK320063FHXY06200634DBD062
- Serial Numbers
- Amount recalled
- 37 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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