Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
This recall has been terminated (originally issued December 23, 2015).
- Company
- Synaptive Medical Inc
- Recall Initiated
- December 4, 2015
- Posted
- December 23, 2015
- Terminated
- March 4, 2016
- Recall Number
- Z-0480-2016
- Quantity
- 8
- Official Source
- View on FDA website ↗
Reason for Recall
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.
Distribution
US: FL, WI, IL, LA, WA.
Lot / Code Info
00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012
Root Cause
Component design/selection
Action Taken
Consignees were sent via courier on 12/4/2015 a Synaptive "Urgent Medical Device Recall" letter dated 30 November 2015. The letter described the problem and the device involved in the recall. Informed consignees that a technical support team member from Synaptive Medical will conduct the field correction. They also requested consignees to complete and return the Recall Response Form. For questions contact Thas Yuwaraj, PhD, .PEng Monday through Friday, 9 AM to 5 PM, Eastern Time at 1-844-462-7246.