Events

Rappel de Device Recall Leica Microsystems Inc.

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 Leica Microsystems, 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
    71928
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2804-2015
  • Date de mise en oeuvre de l'événement
    2015-07-27
  • Date de publication de l'événement
    2015-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139395
  • 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
    Processor, tissue, automated - Product Code IEO
  • Cause
    The asp6025 tissue processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.
  • Action
    Leica sent an Urgent Medical Device Recall Notification letter dated August 11, 2015, to all affected customers via USPS 1st class mail .. Thel letter advised users to 1) do not use the instrument in 3 basket (5L) mode. Instead it advises the customer to change settings to use only the 2 basket (3.8L) mode only. 2) Prompt acknowledgement is requested by the customer 3) when a permanent solution is found a Leiica representative will contact the customer. 4) The Medical Device Recall Notification needs to be passed on to all those who need to be aware within the customers organisation or to any organisation where the potentially affected devices have been transferred. The customer is asked to sign the Medical Device Recall Notification Response Form to confirm that they have received and understand the Medical Device Recall Notification. The customer is requested to confirm receipt of the notice by signing and dating the Acknowledgement Form and faxing it back to Leica at 1-847-236-3747, or scan and email it to LMGRA@leicamicrosystems. com

Device

Device Recall Leica Microsystems Inc.
  • Modèle / numéro de série
    Product Code: Leica ASP6025   Serial Numbers: 163, 169, 200-729, 731, 733, 735, 737, 739, 741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773, 775, 777, 779, 781, 783, 785, 787, 789, 791, 793, 795, 797, 799, 801, 803, 805, 807, 809, 811.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH,PA, SC, TN, TX, VA, WA, WI, WV and District of Columbia. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic , Germany, Spain, France, England, Georgia, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lithuania, Myanmar, Mexico, Malaysia, Netherland, Norway, Peru, Philippines, Poland, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey, Taiwan, and South Africa.
  • Description du dispositif
    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. || The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Adresse du fabricant
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA