Device Recall GlideScope Titanium SingleUse Video Laryngoscope

  • 모델명 / 제조번호(시리얼번호)
    LOT Number ranges:  -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115;
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.
  • 제품 설명
    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. || The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. || Affected Product Names and Part Numbers: || -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) || -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) || -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) || -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) || The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • 제조사 모회사 (2017)
  • Source
    USFDA