Events

Device Recall AMS 800 Urinary Control System Control Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Medical Systems, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58832
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2669-2011
  • 사례 시작날짜
    2011-05-09
  • 사례 출판 날짜
    2011-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100392
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Device incontinence mechanical/hydraulic - Product Code EZY
  • 원인
    American medical systems is recalling all unexpired ams 800 and ams acticon neosphincter control pumps. based upon a review of our product test procedures, we are unable to confirm that all control pumps have met our requirements. test errors could potentially result in a failure to identify a malfunction in the control pump activation mechanism. this malfunction may lead to inadvertent activa.
  • 조치
    American Medical System sent an "URGENT MEDICAL DEVICE RECALL letter dated May 9, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer Customers were instructed to return any existing stock . Please contact American Medical System at 1 (800) 328-3881 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product. For further questions please contact American Medical Systems at 1- (800)328-3881.

Device

Device Recall AMS 800 Urinary Control System Control Pump
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BELGIUM NETHERLANDS, PERU, VENEZUELA, SRI LANKA, PORTUGAL, TUKEY, BRAZIL AUSTRALIA, CZECH REPUBLIC, TUNISIA. LUXWMBOURG, QATAR, SOLOMON ISLANDS, BOSNIA & HERZEGOVIA, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, ECUADOR, ESTONIA, FINLAND, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, POLND, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SLOVENIA, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM and URUGUAY.
  • 제품 설명
    AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 || InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 || The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
  • Manufacturer
    American Medical Systems, Inc.

Manufacturer

American Medical Systems, Inc.
  • 제조사 주소
    American Medical Systems, Inc., 10700 Bren Road West, Minnetonka MN 55343-9679
  • Source
    USFDA