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Terminated

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.

FDA Recall Z-0480-2016 · Posted 2015-12-23

Recalling FirmSynaptive Medical, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2015-12-04
Date Terminated2016-03-04
Product Quantity8

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.

Firm Action

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

Distribution Pattern

US: FL, WI, IL, LA, WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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