Synaptive Medical recalls
Synaptive Medical appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2021-07-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2015-12-30 to 2021-07-07 |
| By agency | FDA Device (5) |
| By classification | Class II (4), Class I (1) |
| By status | terminated (5) |
| Distribution named in notices | CA, FL, IL, IN, LA, MD, MI, NC, NV, NY, OR, PA, SC, TX, US, VA, WA, WI |
Recalls
- Synaptive Trackable Suction Set Standard and Malleable
FDA Device · Class II · 2021-07-07 · Synaptive Medical
Reason: Due to visible burrs/metal filings affixed along the suction tube inner perimeter. - ClearCanvas RIS/PACS
FDA Device · Class II · 2020-04-29 · Synaptive Medical
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. - Synaptive ImageDrive Clinical
FDA Device · Class II · 2020-04-29 · Synaptive Medical
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. - BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party…
FDA Device · Class I · 2018-12-05 · Synaptive Medical
Reason: This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another traject… - Synaptive Medical BrightMatter Navigator System (Guide System)
FDA Device · Class II · 2015-12-30 · Synaptive Medical
Reason: 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) standa…