Device Recall Harmony vLED Surgical Lighting System

  • Modèle / numéro de série
    The following item numbers are included in this recall:  B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russian Federation, Taiwan, and Viet Nam.
  • Description du dispositif
    Harmony¿ vLED Surgical Lighting System, one unit packaged per box || The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Société-mère du fabricant (2017)
  • Source
    USFDA