Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a
FDA device recall Z-0480-2016 · posted 2015-12-23 · Terminated
Recall details
- Recalling firm
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 8
- Distribution
- US: FL, WI, IL, LA, WA.
- Date initiated
- 2015-12-04
- Date posted
- 2015-12-23
- Date terminated
- 2016-03-04
- Location
- Toronto, MaRS Centre South Tower, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHTMATTER NAVIGATION SYSTEM (K142024) | Synaptive Medical, Inc. | 2015-04-02 |