Device Recall GreenLight HPS Fiber Optics, Model Number 102090

  • 모델명 / 제조번호(시리얼번호)
    Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
  • 제품 설명
    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA