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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synaptive Medical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012
Distribution:
Distributed in: US, FL, WI, IL, LA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0480-2016
Related Recalls
Synaptive Trackable Suction Set Standard and Malleable
Synaptive Medical
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
ClearCanvas RIS/PACS
Synaptive Medical
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Synaptive ImageDrive Clinical
Synaptive Medical
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.