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Synaptive Medical Recalls
5 recalls on record · December 30, 2015 to July 7, 2021 · Medical Devices
Recalls by year
15
18
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 7, 2021Medical DevicesFDA
Synaptive Medical Inc recalls Synaptive Trackable Suction Set Standard and Malleable
Hazard: Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
April 29, 2020Medical DevicesFDA
Synaptive Medical Inc recalls Synaptive ImageDrive Clinical
Hazard: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
April 29, 2020Medical DevicesFDA
Synaptive Medical Inc recalls ClearCanvas RIS/PACS
Hazard: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
December 5, 2018Medical DevicesFDA
Synaptive Medical Inc recalls BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can
Hazard: 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 trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
December 30, 2015Medical DevicesFDA
Synaptive Medical, Inc. recalls Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of
Hazard: 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.