Events

Rappel de Device Recall AMS 800 Urinary Control System Control Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par American Medical Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58832
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2669-2011
  • Date de mise en oeuvre de l'événement
    2011-05-09
  • Date de publication de l'événement
    2011-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100392
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Device incontinence mechanical/hydraulic - Product Code EZY
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    American Medical Systems, Inc., 10700 Bren Road West, Minnetonka MN 55343-9679
  • Source
    USFDA