Harmony

  • Modelo / Serial
    2851-1-01 lot number 18YH, 2851-1-30 lot number 18YJ, 2851-2-01 lot number 18YK, 2851-2-30 lot number 18YL, 2851-3-01 lot number 18YM, 2851-3-30 lot number 18YP, 2851-4-01, lot number 18YQ, 2851-4-30 lot number 18YR, 2851-4-31 lot number 18YS, 2851-5-01 lot number 18YT, 2851-5-30 lot number 18YW, 2852-2 lot number 18YT, 2852-4 lot number 18YT, 2854-1 lot number 18YX, 2857-1 lot number 18YZ, 2857-2 lot number 18ZA, 2862-1 lot number 18YY, 2858-1 lot number 18ZB, 2859-1 lot number 18ZC, and 2861-5 lot number 18ZD
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT, MO, IN, NV, OR, SD, IL, NJ, WI, OK, FL, GA, VA, NC, MD
  • Descripción del producto
    Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spinal Concepts, Inc, 5301 Riata Park Ct Bldg F, Austin TX 78727-3436
  • Source
    USFDA

42 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    The following item numbers are included in this recall:  B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    Serial number 10502
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
  • Descripción del producto
    Magnetom Harmony MRI System Model number 7106714
  • Manufacturer
  • Modelo / Serial
    Serial number 15002
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
  • Descripción del producto
    Magnetom Harmony MRI System Model number 5751438
  • Manufacturer
  • Modelo / Serial
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada.
  • Descripción del producto
    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Manufacturer
  • Modelo / Serial
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada.
  • Descripción del producto
    Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
  • Manufacturer
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