Device Recall LAP Surgical Transducer

  • Model / Serial
    16 devices are identified with Serial Numbers:  038VWM, 038FK1, 0379P6, 038G67, 038VWK, 038192, 0379P1, 0379P2, 038FJZ, 038FJW, 0379P0, 0379P5, 037WMJ, 038VWP, 037XT6, and 038153.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
  • Product Description
    Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA