Harmony

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    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
  • 제품 설명
    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

제조사

  • 제조사 주소
    Spinal Concepts, Inc, 5301 Riata Park Ct Bldg F, Austin TX 78727-3436
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 42 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    The following item numbers are included in this recall:  B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial number 10502
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Magnetom Harmony MRI System Model number 7106714
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial number 15002
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Magnetom Harmony MRI System Model number 5751438
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
  • Manufacturer
하나 더 37 건 더