Devices

Harmony

  • Model / 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
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    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
  • Product Description
    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
    Spinal Concepts, Inc
  • 1 Event

Manufacturer

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

42 devices with a similar name

Learn more about the data here

Device Recall Harmony vLED Surgical Lighting System
  • Model / Serial
    The following item numbers are included in this recall:  B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Steris Corporation
Device Recall Magnetom Harmony
  • Model / Serial
    Serial number 10502
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Magnetom Harmony MRI System Model number 7106714
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Magnetom Harmony
  • Model / Serial
    Serial number 15002
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Magnetom Harmony MRI System Model number 5751438
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Model / Serial
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Manufacturer
    Draeger Medical, Inc.
Device Recall Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
  • Model / Serial
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
  • Manufacturer
    Draeger Medical, Inc.
37 more