Device Recall HARMONIC ACE Shears Adaptive Tissue Technology

  • 모델명 / 제조번호(시리얼번호)
    P9125C,  P93T5J,  P93T5K,  P93V06,  P93W4Y,  P93Y4A,  P93W8A, P9400F,  P9409V,  P94A93,  P94A94,  P94C8R,  P94G1W,  P91F4A,  P91F86,  P93M3W,  P93W0A,  P93Z4X,  P93Z96,  P94E6U,  P94H32,  P94H9V,  P94J28
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.
  • 제품 설명
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 || Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • 제조사 모회사 (2017)
  • Source
    USFDA