Events

Rappel de Device Recall MRidium 1145 Dose Reduction System (DERS)

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 Iradimed Corporation.

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
    65778
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1874-2013
  • Date de mise en oeuvre de l'événement
    2013-07-01
  • Date de publication de l'événement
    2013-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120124
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    The dose error reduction system (ders) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. this can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
  • Action
    The firm, Iradimed Corporation, notified by phone and sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email dated July 1, 2013 all consignees/customers. The notice described the product, problem and action to be taken. The customers were instructed to identify the MRidium 3860+ MR Infusion Pumps which have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time; however, if they are installed-remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided. Product will be reconditioned by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle. Should your users have any questions following these instructions, please contact Iradimed Customer Service; 866-677-8022 (toll free) or 407-677-8022 ext. 100 or via e-mail - recallsupport@iradimed.com

Device

Device Recall MRidium 1145 Dose Reduction System (DERS)
  • Modèle / numéro de série
    Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.
  • Description du dispositif
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). || The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
  • Manufacturer
    Iradimed Corporation

Manufacturer

Iradimed Corporation
  • Adresse du fabricant
    Iradimed Corporation, 7457 Aloma Ave, Suite 201, Winter Park FL 32792-9172
  • Société-mère du fabricant (2017)
    IRadimed Corp.
  • Source
    USFDA