Devices

Device Recall Nexstim

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11201252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS13481286N4, NBS14011288N4, NBS14361295N5, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS14011288N4, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, NBS15271305N5, NBS15371307N5, NBS16031313N5 and NBS16221316N5. Additionally in Nexstim's warehouse (i.e. not distributed NBS 11201256N4, NBS 13481286N4, NBS 14361295N5 and NBS 16371318N5)
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to GA only, Foreign: Europe
  • 제품 설명
    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. || The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
  • Manufacturer
    Nexstim PLC
  • 1 Event

제조사

Nexstim PLC
  • 제조사 주소
    Nexstim PLC, Elimaenkatu 9B, Helsinki Finland
  • 제조사 모회사 (2017)
    Nordea Bank Ab
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Nexstim
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to GA only, Foreign: Europe
  • 제품 설명
    Nexstim eXima NBS System Software version 2.2 or higher. || The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
  • Manufacturer
    Nexstim PLC