Drug recall
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is…
FDA recall event 72747 · Class II · Synaptive Medical, Inc.
Key facts
| Event ID | 72747 |
|---|---|
| Recall numbers | Z-0480-2016 |
| Recalling firm | Synaptive Medical, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 4, 2015 |
| Report date | Dec 30, 2015 |
| Termination date | Mar 4, 2016 |
| City | Toronto |
| Country | Canada |
| FEI number | 3010439744 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: