Olympus Corporation of the Americas recalls Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Nee
Recalled Product
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)
Hazard / Issue
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Issued by
FDA
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