Z-0480-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- December 4, 2015
- Termination Date
- March 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
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.
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 Pattern
US: FL, WI, IL, LA, WA.
Code Information
00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012