Events

Rappel de Device Recall IMRIS ORT100 Table

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 Deerfield Imaging, 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
    79488
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1263-2018
  • Date de mise en oeuvre de l'événement
    2018-02-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162455
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Cause
    The operating room table may drift while in use, which could potentially result in unintended movement of the table.
  • Action
    The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS. IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@imris.com if you have any questions or concerns."

Device

Device Recall IMRIS ORT100 Table
  • Modèle / numéro de série
    (a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10003241, 10002607, 10002848, 10005651, 10007348, 10007424, 10004250, 10004439, 10004576, 10006438, 100030007, 10006887, 10006886 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003065
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US, Canada, China, Australia, Sweden, Germany
  • Description du dispositif
    IMRIS ORT100 Table, Part Numbers: || (a) 110470-000 || (b) 110470-600
  • Manufacturer
    Deerfield Imaging, Inc.

Manufacturer

Deerfield Imaging, Inc.
  • Adresse du fabricant
    Deerfield Imaging, Inc., 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Société-mère du fabricant (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA