Device Recall TX1 Tissue Removal System Console

  • Model / Serial
    Product Codes: LFL, GEI,  Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: MN only.
  • Product Description
    TX1 Tissue Removal System Console. Model: TX1 || TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. || Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    American Optisurgical Inc, 26902 Vista Ter, Lake Forest CA 92630-8123
  • Source
    USFDA